536 BPG Assessment Foot Ulcer 1
536 BPG Assessment Foot Ulcer 1
Executive Director
Registered Nurses Association of Ontario
Team Leader
Acute Care Nurse Practitioner Wound Care
St. Michaels Hospital
Toronto, Ontario
IIWCC completed
Nurse Clinician, Skin and Wound Care
Credit Valley Hospital
Mississauga, Ontario
Karen Bruton, RN
IIWCC completed
ONA Representative (Local 105 Coordinator)
Clinical Resource Nurse
Northumberland Hills Hospital
Cobourg, Ontario
Diabetes Educator
Trillium Health Centre Diabetes Centre
Toronto, Ontario
IIWCC completed
Wound Care Specialist and
Clinical Trials Coordinator
Dermatology Office of Dr. R. Gary Sibbald
Mississauga, Ontario
Declarations of interest and confidentiality were made by all members of the guideline development panel.
Further details are available from the Registered Nurses Association of Ontario.
Bonnie Russell, BJ
Program Assistant
Carrie Scott
Administrative Assistant
Julie Burris
Administrative Assistant
Advisory Panel
Lynn Baughan, RN, BScN, CDE
Jos Contreras-Ruiz, MD
Acknowledgement
Stakeholders representing diverse perspectives were solicited for their feedback and the Registered Nurses Association
of Ontario wishes to acknowledge the following for their contribution in reviewing this Nursing Best Practice Guideline.
Debra Clarke, RN
Enterostomal Nurse Consultant, David Thompson Health Region, Red Deer, Alberta
Jos Contreras-Ruiz, MD
Collaborative Care Facilitator, North Bay General Hospital, North Bay, Ontario
Professional & Technical Services for IV, Site Care Management and Wound Care,
3M Canada, London, Ontario
Cindy Lazenby, RN
Corinne Racioppa, RN
Table of Contents
Summary of Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Interpretation of Evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Responsibility for Guideline Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Purpose & Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Guideline Development Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Definition of Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Background Context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Pathway to Diabetic Foot Ulcers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Guiding Principles in the Care of Patients with Diabetic Foot Ulcers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Practice Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Education Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Organization & Policy Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Research Gaps & Future Implications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Evaluation & Monitoring of Guideline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Implementation Strategies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Process for Update/Review of Guideline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Summary of Recommendations
RECOMMENDATION
*LEVEL OF EVIDENCE
Practice Recommendations
Patient Empowerment
and Education
Holistic Assessment
1.0 All patients with diabetic foot ulcer(s) (PWDFU) or caregivers should have an
understanding of their condition and the resources available to optimize their
general health, diabetes management and ulcer care.
Ia
IV
IV
Ib IV
Vascular Status
2.1 Clinically assess bilateral lower extremities for vascular supply and facilitate
appropriate diagnostic testing.
IIb IV
Infection
2.2 Assess all patients with diabetic foot ulcers for signs and symptoms of infection
and facilitate appropriate diagnostic testing and treatment.
Neuropathy
II IV
Foot Deformity
and Pressure
2.4 Assess for foot pressure, deformity, gait, footwear and devices. Facilitate
appropriate referrals.
Ia IV
Foot Ulcer
Assessment
IIa
IV
Ia IV
IV
4.0 Define goals based on clinical findings, expert opinion and patient preference.
IV
IV
4.2 Develop goals mutually agreed upon by the patient and healthcare professionals.
IV
5.0 Identify and optimize systemic, local and extrinsic factors that can influence
wound healing.
IV
Systemic Factors
5.1 Modify systemic factors and co-factors that may interfere with or impact on
healing.
IV
Local Factors
5.2 Provide local wound care considering debridement, infection control and
a moist wound environment.
Extrinsic Factors
Goals of Care
Management
10
Ia-III
IIa
RECOMMENDATION
Non-healing diabetic
foot wounds
Evaluation
LEVEL OF EVIDENCE
IV
IV
Reassess
6.1 Reassess for additional correctable factors if healing does not occur
at the expected rate.
III-IV
Other therapies
6.2 Consider the use of biological agents, adjunctive therapies and/or surgery
if healing has not occurred at the expected rate. Review each specific modality
for recommendations.
Ia-IV
Education Recommendations
Continuing
Professional
Development
7.0 Nurses and other members of the interdisciplinary team need specific
knowledge and skills in order to competently assess and participate in the
treatment of diabetic foot ulcers.
IV
Curriculum
Support and Resources
8.0 Educational institutions are encouraged to incorporate the RNAO Nursing Best
Practice Guideline Assessment and Management of Foot Ulcers for People with
Diabetes into basic RN, RPN, MD and allied health professional curricula.
IV
9.0 Nursing best practice guidelines can be successfully implemented only where
there are adequate planning, resources, organizational and administrative
support, as well as appropriate facilitation. Organizations may wish to develop
a plan for implementation that includes:
An assessment of organizational readiness and barriers to education.
Involvement of all members (whether in a direct or indirect supportive
function) who will contribute to the implementation process.
Dedication of qualified individual(s) to provide the support needed
for the development and implementation process.
Ongoing opportunities for discussion and education to reinforce
the importance of best practices.
Opportunities for reflection on personal and organizational experience
in implementing guidelines.
IV
IV
Team Development
IV
11
RECOMMENDATION
LEVEL OF EVIDENCE
Partnerships
9.3 Organizations are encouraged to work with community and other partners
to develop a process to facilitate patient referral and access to local diabetes
resources and health professionals with specialized knowledge in diabetic foot
ulcer management.
IV
Financial Support
9.4 Organizations are encouraged to advocate for strategies and funding to assist
patients in obtaining appropriate pressure redistribution devices.
IV
Advocacy
IV
Interpretation of Evidence
Levels of Evidence
Ia Evidence obtained from meta-analysis or systematic review of randomized controlled trials.
Ib Evidence obtained from at least one randomized controlled trial.
IIa Evidence obtained from at least one well-designed controlled study without randomization.
IIb Evidence obtained from at least one other type of well-designed quasi-experimental study,
without randomization.
III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative
studies, correlation studies and case studies.
12
13
Seven guidelines were critically appraised with the intent of identifying existing guidelines that were
current, developed with rigour, evidence-based and which addressed the scope identified by the panel for
the best practice guideline. A quality appraisal was conducted on these seven clinical practice guidelines
using the Appraisal of Guidelines for Research and Evaluation Instrument (AGREE Collaboration, 2001). This
process yielded a decision to work primarily with the following seven guidelines.
Australian Centre for Diabetes Strategies (2001). National evidence based guidelines for the
management of type 2 diabetes mellitus Draft for public consultation 6 April 2001 for the
identification & management of diabetic foot disease. Australian Centre for Diabetes Strategies
[Electronic version].
Available: http://www.diabetes.net.au/PDF/evidence_based_healtcare/FootProblems.pdf
CREST Clinical Resource Efficiency and Support Team (1998). Guidelines for the management of
the diabetic foot: Recommendations for practice. Clinical Resource Efficiency and Support Team
[Electronic version]. Available: http://www.crestni.org.uk/publications/diabetic_foot.pdf
Frykberg, R. G., Armstrong, D. G., Giurini, J., Edwards, A., Kravette, M., Kravitz, S. et al. (2000).
Diabetic foot disorders: A clinical practice guideline. American College of Foot and Ankle Surgeons
[Electronic version]. Available: http://www.acfas.org/diabeticcpg.html
14
Hutchinson, A., McIntosh, A., Feder, R.G., Home, P. D., Mason, J., OKeefee, C. et al. (2000). Clinical
guidelines and evidence review for type 2 diabetes: Prevention and management of foot problems.
Royal College of General Practitioners [Electronic version]. Available:
http://www.rcgp.org.uk/rcgp/clinspec/guidelines/diabetes/contents.asp
Inlow, S., Orsted, H., & Sibbald, R. G. (2000). Best practices for the prevention, diagnosis and
treatment of diabetic foot ulcers. Ostomy/Wound Management, 46(11), 55-68.
Ministry of Health Malaysia (2003). Clinical practice guidelines: Management of diabetic foot. Ministry
of Health Malaysia [Electronic version]. Available:
http://www.acadmed.org.my/cpg/Draft%20CPG%20%20management%20of%20diabetic%20foot.pdf
Royal Melbourne Hospital (2002). Evidence based guidelines for the inpatient management of acute
diabetes related foot complications. Melbourne Health [Electronic version]. Available:
http://www.mh.org.au/ClinicalEpidemiology/new_files/Foot%20guideline%20supporting.pdf
The panel members divided into subgroups to undergo specific activities using the short-listed guidelines,
other literature and additional resources for the purpose of drafting recommendations for nursing
interventions. This process yielded a draft set of recommendations.
An advisory panel was recruited to review and provide feedback on the draft recommendations. The
advisory panel represented physicians, other healthcare disciplines as well as professional associations. An
acknowledgement of the advisory panel is provided at the front of this document. Feedback on the
recommendations was obtained from healthcare consumers through a focus group. The panel members as
a whole reviewed the recommendations and the feedback from the advisory panel and consumers,
discussed gaps and available evidence, and came to a consensus on a draft guideline.
This draft was submitted to a set of external stakeholders for review and feedback of the content. It was also
critiqued using the AGREE instrument (AGREE Collaboration, 2001). An acknowledgement of these reviewers is
provided at the front of this document. Stakeholders represented healthcare consumers, various healthcare
disciplines as well as professional associations. External stakeholders were provided with specific
questions for comments, as well as the opportunity to give overall feedback and general impressions. The
results were compiled and reviewed by the development panel. Discussion and consensus resulted in
revision to the draft document prior to publication.
15
Definition of Terms
An additional Glossary of Terms related to clinical aspects of the document is located in Appendix B.
Evidence: An observation, fact or organized body of information offered to support or justify inferences
or beliefs in the demonstration of some proposition or matter at issue (Madjar & Walton, 2001, p.28).
Meta-Analysis: The use of statistical methods to summarize the results of independent studies,
thus providing more precise estimates of the effects of healthcare than those derived from the
individual studies included in a review (Alderson, Green & Higgins, 2004).
Practice Recommendations:
Randomized Controlled Trial: For the purposes of this guideline, a study in which subjects
are assigned to conditions on the basis of chance, and where at least one of the conditions is a control
or comparison condition.
16
Background Context
Diabetes mellitus is serious, complex, life-long condition affecting 4.2% of the worlds population
and 1.5 million Canadians (Boulton, Meneses, & Ennis, 1999; Canadian Diabetes Association (CDA), 1998). Diabetes
seriously burdens individuals, their families and society. It is estimated that the cost of diabetes and its
chronic complications range from 4.6 to 13.7 billion U.S. dollars annually (Dawson, Gomes, Gerstein, Blanchard
& Kahler, 2002; Gordois, Scuffham, Shearer, Oglesby & Tobian, 2003). The aboriginal (First Nations, Metis and Inuit)
population in Canada demonstrates a prevalence of type 2 diabetes that is at least three times the national
average (Health Canada, 2000; 2002; Indian and Inuit Health Committee & Canadian Pediatric Society, 1994). This increased
incidence is reflected in high rates across all age groups. It is important to note that Aborignal ancestry has
been identifed as an independent risk factor for diabetes and despite this fact, little is known of this
particular group (Health Canada, 2000; 2002; Young, 2003; Young, Szathmary, Evers & Wheatley, 1990).
There are two major classifications of diabetes; Type 1 and Type 2. Type 1 diabetes, which affects 10-15% of
all people with diabetes, is primarily the result of the inability to produce insulin due to beta cell
destruction in the pancreas. While Type I diabetes accounts for fewer individuals with diabetes, it results in
a disproportionately higher frequency of diabetes related complications. Type 2 diabetes, affecting over
80% of those diagnosed with diabetes, results from a combination of insufficient insulin production and/or
resistance of the cells of the body to the actions of insulin (RNAO, 2004).
Control of blood glucose levels is paramount to minimizing complications related to diabetes (Diabetes
Control and Complication Trial (DCCT) Research Group, 1993; United Kingdom Prospective Diabetes Study (UKPDS) Group 33,
1998). This is achieved through lowering serum glucose using oral hypoglycemic agents, and/or
subcutaneous injections of insulin, dietary restriction and regular exercise. Other factors contributing to
delayed onset of complications include control of hypertension, hyperlipidemia and hyperinsulinemia.
Unfortunately, these treatments may not completely control the progression of diabetes-related changes
including neuropathy (CDA, 1998).
17
Regardless of the type of diabetes classification, over time, failure to achieve optimal glycemic control can
cause damage to the bodys small and large blood vessels and nerves. Damage to these vessels and nerves
can affect all organs in the body; however, the eyes, heart, kidneys, and skin are most commonly affected
in patients with diabetes.
These changes along with those previously mentioned lead to a cascade of events resulting in changes to
the foot itself. According to Boulton, Kirsner, & Vileikyte (2004), the triad of neuropathy, deformity and
trauma is present in almost two thirds of patients with foot ulcers (p. 49). The structural changes discussed
along with vascular insufficiency, infection and pressure predispose the person with diabetes (PWD) to
develop a foot ulceration (See Figure 1: Pathway to Diabetic Foot Ulcers).
In industrialized countries, diabetes is the leading cause of non-traumatic, lower extremity amputations
(American Diabetes Association (ADA), 1999; Foundation for Accountability, 1996). Approximately 15% of all persons
with diabetes (PWD) will develop a foot ulcer at some time during the course of their disease (ADA, 1999).
Eighty-five percent of lower extremity amputations are preceded by foot ulcers (Reiber, Boyko & Smith, 1995).
Of these, 14% to 24% will proceed to major amputation (Ramsey, Newton, Blough, McCulloch, Sandhu, Reiber et al.,
1999). Neuropathy is most commonly associated with the development of diabetic foot ulcers, but the
presence or co-existence of peripheral vascular disease and infection can also lead to skin breakdown. It is
widely known that diabetic foot ulceration is a significant end-stage complication of diabetes (Boulton et al.,
1999). Moreover, the risk of amputation increases 10-fold in patients with diabetes and concurrent end
stage renal disease (ESRD)(Eggers, Gohdes & Pugh, 1999).
It should be emphasized that the most common offending agent or cause of traumatic foot ulceration is
footwear (Birke, Patout Jr. & Foto, 2000; Tyrrell, 2002). The use of ill-fitting shoes are instrumental in the
development of blisters, callus and corns which can lead to ulceration in patients with diabetes. In
particular, peripheral neuropathy in people with diabetes leads to a cascade of events resulting in changes
to the foot itself. These changes, along with those previously mentioned, predispose the patient with
diabetes to the development of ulceration.
Given the data on the burden of illness and the significant long-term impact on health of people with
diabetes, care of persons with diabetic foot ulcers demands a systematic, team approach from healthcare
professionals (Dargis, Pantlejeva, Jonushaite, Vileikyte & Boulton, 1999; Sumpio, 2000). The development panel
recognizes the complexity of the treatment of individuals with diabetic foot ulcers, and acknowledges the
stressful conditions in which nurses work, in particular, the demands on the time of nurses in various
practice settings. To this end, the recommendations serve as a guide for nurses to identify and assess
patients in high risk groups who would benefit from specialized wound care. A specialized interdisciplinary
team should work closely with patients and their families to address the complex lifestyle, self-care and
multiple treatment demands of patients who have a diabetic foot ulcer. It is acknowledged that this level of
care is not yet accessible to or accessed by all people with diabetes. Moreover, fewer patients with foot
ulcerations receive optimal wound management (Boulton et al., 2004). Nurses can facilitate and positively
influence wound healing outcomes by promoting, collaborating and participating in interdisciplinary care
teams who follow best practice guidelines similar to those presented in this document.
18
Diabetes Mellitus
O2 and
medication
delivery
impaired
Neuropathy
Sensory loss
of protective
sensation
Autonomic
skin changes
Motor foot
deformity
Autonomic/
Motor
Limited joint
mobility
Poor healing
Self care deficit
Poor glucose control
Improper footwear
Obesity
Ulceration
Infection
Amputation
19
5. The V. I. P. principle (Vascular supply, Infection, and Pressure redistribution) guides the
assessment and management of diabetic foot ulcers.
6. Nurses and their interdisciplinary colleagues demonstrate integration of the best evidence
for practice and expertise in local wound care.
7. Patients with diabetes who are aware of their risk category and management strategies can
reduce ulcer re-ocurrence. Nurses and their interdisciplinary colleagues have a role in educating
their patients about reducing ulcer recurrence and further foot complications. Hence, it is highly
recommended by the development panel to implement this guideline in conjuction with the
RNAO (2004) Best Practice Guideline entitled Reducing Foot Complications for People with
Diabetes. This guideline is available to download at www.rnao.org/bestpractices.
8. Ulcer healing of patients with diabetes, improvement of quality of life and reduction in
amputation rate requires the successful implementation of a comprehensive foot ulcer program.
10. Diabetic foot ulcer program outcomes should be evaluated and benchmarked for
continuous quality improvement.
20
Practice Recommendations
Patient Empowerment and Education:
Recommendation 1.0:
All patients with diabetic foot ulcer(s)(PWDFU) or caregivers should have an understanding of their
condition and the resources available to optimize their general health, diabetes management and
ulcer care. (Level of Evidence =1a)
Discussion of Evidence:
In order to address the many individual variables involved in learning, the process of educating patients
with diabetes has become participative rather than didactic (Whittemore, 2000). Evidence supports
educational intervention for improvement in foot care knowledge and behaviour in the short term for
people with diabetes (Hutchinson et al., 2000; Valk, Kriegsman, & Assendelft, 2002). There is additional evidence to
support that people with diabetes who are at a higher risk for foot ulceration significantly benefit from
education and regular reinforcement of that education (ADA, 2001; CDA, 1998; 2003; Mason, OKeefee, Hutchinson,
McIntosh, Young & Booth, 1999a; The University of York NHS Centre for Reviews and Dissemination, 1999; New Zealand
Guidelines Group (NZGG), 2000). A three-fold increased amputation risk was demonstrated by Reiber, Pecoraro
& Koepsell (1992) for those people with diabetes who had not received formal diabetes education,
suggesting significant prevention is possible with appropriate teaching strategies.
Expert opinion supports the need for reinforcement of basic foot care education in patients with diabetes
and established foot ulcers. Nurses, as the single largest group of health professionals working in a range of
settings, are well positioned to monitor risk status for re-occurrence, identify new or deteriorating ulcers
and provide and/or reinforce basic foot care education. They may act as the primary diabetes foot care
educator, or as a link between patients and their primary care providers or within specialized diabetes care
teams (RNAO, 2004).
Recommendation 1.1:
Education is essential as an empowerment strategy for diabetes self-management and prevention
or reduction of complications. (Level of Evidence = IV)
Discussion of Evidence:
Diabetes education should be interactive, solution-focused and based on the experiences of the learner. It should
be staged and tailored to meet individual needs and abilities. The education of patients should be in keeping
with the principles of adult learning using a client-centred approach (Glasgow, 1999). The nurse should be sensitive
to socioeconomic, cultural, psycho-social and other individual domains when planning all interventions.
Randomized controlled trials evaluating education for people with diabetes are of poor quality and have significant
methodological issues (Valk, Kriegsman & Assendelft, 2004). The existing evidence, however, does indicate that foot
care knowledge and patient behaviour is positively influenced, albeit for a short time period, and education may
be of particular benefit to those patients at high risk (Valk et al., 2004). Group education and sustained long-term
follow-up have both been shown to enhance knowledge and produce positive outcomes (CDA, 2003).
21
Recommendation 1.2:
Education is based on identified individual needs, risk factors, ulcer status, available resources and
ability to heal. (Level of Evidence = IV)
Discussion of Evidence:
As visible care providers across the continuum, nurses are in a unique position to promote the maintenance
of healthy feet, identify problems at any stage, positively influence self-care practices, and refer higher risk
individuals for expert care (RNAO, 2004).
There is evidence that diabetes self-care behaviours influence blood glucose control. Improved glycemic
control facilitates healing of foot ulcers and delays and/or prevents diabetes related complications that
further contribute to peripheral neuropathies and reduced lower extremity circulation (DCCT Research Group,
1993; RNAO, 2004; UKPDS Group 33, 1998).
The needs assessment should be the driving force for individual program planning and management.
These assessments need to be tailored to determine appropriate allocation of personnel and resources to
ensure the education and healthcare needs of the individual are met (ADA, 1999). Personal attitudes and
cultural beliefs, level of literacy, age and physical condition will all influence the individuals ability to carry
out the recommended regimen (American Association of Diabetes Educators, 1999; Canadian Diabetes Association
Diabetes Educator Section, 2000).
Although education seems to have short term positive impact on foot care knowledge and patient
behaviour, it is uncertain whether it can prevent foot ulceration and amputation. In a systematic review
examining patient education regarding diabetic foot ulceration, Valk et al. (2002), conclude that further
research is required to recognize the impact of patient education on ulcer incidence and whether
education has different effects for individuals with different levels of risk of ulcer development.
As discussed in the best practice guideline Reducing Foot Complications for People with Diabetes (RNAO,
2004), the following elements should be included in basic foot care programs:
See Appendix C for the University of Texas Foot Classification System Categories 0-3: Risk Factors for Ulceration.
22
See Appendix D for the University of Texas Foot Classification System Categories 4-6: Risk Factors for
Amputation
See Appendix E for the University of Texas Health Science Center San Antonio Diabetic Wound
Classification System.
See Appendix F for patient handout on diabetic foot care.
Holistic Assessment:
Recommendation 2.0:
Complete and document a health history, including diabetes management, allergies, medications,
functional assessment and physical examination (vascular status, infection, callus, neuropathy,
foot deformity/pressure, ulcer). (Level of Evidence = Ib IV)
The holistic assessment of patients with diabetes and foot ulceration should include:
History of presenting illness (Level of Evidence = IV)
Initiating event (trauma, shoe wear, etc.)
Duration of ulceration
Treatments prescribed
Outcome of the treatments
Past medical history (Level of Evidence = III)
Medications (Level of Evidence = IV)
Current diabetes management (Level of Evidence = Ib)
Allergies (Level of Evidence = IV)
Family history (Level of Evidence = III)
Activities of Daily Living (ADL)/Instrumental Activities of Daily Living (IADL)
or functional assessments (Level of Evidence = III)
Quality of life (Level of Evidence = III)
Discussion of Evidence:
A comprehensive assessment is required for all patients who present with diabetic foot ulceration.
This assessment must include the etiology, factors that influence healing and the patients
biopsychosocial status.
Initiating event
Duration of ulceration
Treatments prescribed
Outcome of the treatments
The evaluation of the patient with a diabetic foot ulcer requires a detailed history and physical
examination, appropriate diagnostic tests, and identification of risk factors for ulceration. People with
diabetic foot ulcers should be identified as high risk for amputation (Australian Centre for Diabetes Strategies,
2001; Falanga & Sabolinski, 2000).
23
24
normal range effectively delayed the onset and slowed the progression of diabetic retinopathy,
nephropathy and neuropathy in patients with insulin dependent diabetes (IDDM), now identified as type 1.
A Japanese study examining glycemic control and microvascular complications concluded that intensive
glycemic control can delay onset and progression of diabetic retinopathy, nephropathy and neuropathy in
Japanese patients with NIDDM (type 2 diabetes)(Ohkubo, Kishikawa, Araki, Miyata, Isami, Motoyoshi et al., 1995).
The Wisconsin Epidemiologic Study of diabetes retinopathy showed a consistent exponential relationship
between worsening glycemic control and complications (Moss, Klein & Klein, 1996). The CDA Clinical Practice
Guidelines (2003) recommends the following targets for glycemic control for most patients with type 1 and
type 2 diabetes:
A1C < 7.0% to reduce the risk of microvascular and macrovascular complications.
Fasting plasma glucose of 4.0 to 7.0 mmol/L and 2-hour postprandial plasma glucose
targets of 5.0 to l0.0 mmol/L.
The CDA (2003) advises that treatment goals and strategies must be individualized according to risk factors
such as complications and co-morbidities.
25
Vascular Status:
Recommendation 2.1:
Clinically assess bilateral lower extremities for vascular supply and facilitate appropriate
diagnostic testing. (Level of Evidence = IIb IV)
The assessment of vascular supply can be achieved through history, physical examination and diagnostic tests.
Diagnostic Tests*
Peripheral pulses
Intermittent claudication
Transcutaneous oxygen
Temperature
Capillary refill
Edema
Pain
Dry gangrene
Discussion of Evidence:
The affected foot must have adequate blood flow to support healing (Birke et al., 2000; Reiber et al., 1999). The
literature supports the notion that peripheral arterial disease (PAD), also known as peripheral vascular
disease (PVD), is not the cause of skin breakdown alone, but can prolong wound healing and increase the
risk of subsequent amputation (Apelqvist, 1998; Birke et al., 2000; Crane & Branch, 1998; Sinacore & Mueller, 2000). In
persons with diabetes seen at a younger age, PAD is often bilateral. Moreover, risk of PAD increases with the
duration of the disease (Calhoun, Overgaard, Stevens, Dowling & Mader, 2002). Furthermore the risk of PAD
increases by ten-fold in those with diabetes and concurrent renal failure (Apelqvist, 1998; Eggers et al., 1999).
The presence of peripheral pedal pulses represents a minimum systolic pressure of 80 mmHg (Lavery &
Gazewood, 2000). The National Evidence Based Guidelines for the Management of Type 2 Diabetes Mellitus
(Australian Centre for Diabetes Strategies, 2001) states that the absence of peripheral pulses has prognostic
significance for future amputation in people with or without foot ulceration. With the distal nature of the
disease process, persons with diabetes may have ischemia in the presence of dorsalis pedis pulses (Boulton
et al., 1999).
One of the first classical symptoms of vascular insufficiency is claudication (calf pain). However, in patients
with diabetes, this classic symptom can be masked by the presence of neuropathy (Calhoun et al., 2002). A
cohort study by Eneroth, Apelqvist & Stenstrom (1997), found that claudication was an insignificant
predictor or symptom of vascular disease. A positive history of lower limb intermittent claudication
combined with non-palpable pedal pulses bilaterally increases the probability of vascular insufficiency in
diabetes (Boyko, Ahroni, Davignon, Stensel, Prigeon & Smith, 1997).
26
Capillary refill is defined as abnormal if it takes longer than 5 seconds for the tissue to return to its normal
colour after applying pressure and releasing it.
The colour of the foot should be assessed for rubor on dependency, pallor on elevation, mottling and dry
gangrene, all of which are signs of ischemia (Bowker & Pfeifer, 2001). A vascular surgery referral is
recommended for patients with signs of arterial insufficiency in order that a comprehensive vascular
assessment can be completed.
See Appendix G for further details about diagnostics to determine vascular supply.
Infection:
Recommendation 2.2:
Assess all patients with diabetic foot ulcers for signs and symptoms of infection and facilitate
appropriate diagnostic testing and treatment. (Level of Evidence = IIa)
Discussion of Evidence:
Persons with diabetic foot ulcers may not be able to mount an inflammatory response due to impaired
immunodefense, decreased peripheral circulation and metabolic control (Armstrong, Lavery, Sariaya & Ashry,
1996; Eneroth et al., 1997). In addition, increased co-morbidities associated with aging places the person with
diabetes at a higher risk for infection.
Identifying infection in a chronic wound can be a challenge since the clinical assessment for infection in chronic
wounds differs from acute wounds. Gardner, Frantz & Doebbling (2001) validated the work by Cutting &
Harding (1994) and provided a checklist to aid the clinician in identifying the clinical signs of infection in chronic
wounds. Gardner et al. (2001), in a cross-sectional design study, identified the following signs and symptoms:
Increased pain (100% specificity)
Wound breakdown (100% specificity)
Friable granulation tissue (76% specificity)
Foul odour (88% specificity)
Deep infection will often cause erythema and warmth extending 2 cm or more beyond the wound margin.
This increased inflammatory response is painful and will cause the wound to increase in size or lead to
satellite areas of tissue breakdown which cause adjacent ulceration. Deep infections, especially in ulcers of
long duration can often lead to osteomyelitis. Probing to bone is a simple, non-invasive technique for rapid
identification of osteomyelitis and should be included in the initial assessment of all patients with
infected pedal ulcers (Grayson, Balaugh, Levin & Karchmer, 1995). When combined with clinical evaluation and
radiographic interpretation, probing to bone is a cost-effective and specific assessment tool (Caputo,
Cavanagh, Ulbrecht, Gibbons & Karchmer, 1994).
With infection, the wound may change in odour, colour, tissue quality and exudates. A healthy wound has
a faint but not unpleasant odour, infections usually result in a distinctive and slightly unpleasant smell
(Cutting & Harding, 1994).
27
Based on the utilization of the signs and symptoms listed below, the timely diagnosis and treatment of
infection is vital to the healing of diabetic foot ulcers. Deep foot infections are serious, potentially limb
threatening and have been identified as the immediate cause of 25-51% of amputations in persons with
diabetes (Tennvall, Apelqvist & Eneroth, 2000).
Table 1: Clinical signs and symptoms of impaired bacterial balance in persons with a diabetic foot ulcer
SIGNS OF DEEP WOUND AND SYSTEMIC SIGNS OF INFECTION ARE POTENTIALLY LIMB
AND/OR LIFE THREATENING. THESE CLINICAL SIGNS AND SYMPTOMS REQUIRE
URGENT MEDICAL ATTENTION.
Non-healing
Swelling, induration
Fever
Rigours
Wound breakdown
Chills
Increased exudate
Hypotension
Undermining or tunnelling
Multi-organ failure
Probing to bone
Foul odour
Flu-like symptoms
Anorexia
Infection occurs when bacteria in a wound overcomes the natural defences of the hosts immune system.
The likelihood of a wound becoming infected is related to microbial load and the type of micro-organism.
However, equally important factors are the characteristics of the wound (type, site, size and depth), the
level of blood perfusion and the ability of the host to resist infection:
Infection
Number of organisms
x
Virulence of organisms
Host resistance
This equation represents a balance between increasing number of organisms and virulence that can eventually
overcome the hosts ability to contain infection (Dow, Browne & Sibbald, 1999; Peacock & Van Winkle, 1976).
While emphasis is frequently placed on bacterial burden, the host resistance (the patient with diabetes) is often
the critical factor in determining whether infection will develop. Persons with diabetes have compromised
immunity which leads to a reduced resistance to infection.
28
Most chronic wounds contain more than three species of micro-organisms, which increases the risk of
infection as they may develop synergies with one another. In wounds that are infected with a number of
species it is not possible to distinguish which is the causative organism (Table 2).
Type of micro-organism
Cutaneous flora
1 to 4 weeks
Purulent discharge
Gram-positive
S. aureus.
Single species
Tissue necrosis
Undermining
Deep involvement
4 weeks onwards
Used with permission. Dow, G., Browne, A. & Sibbald, R. G. (1999). Infection in chronic wounds:
Controversies in diagnosis and treatment. Ostomy/Wound Management, 45(8), 23-27, 29-40.
Diagnostic tests and imaging are other procedures that are used to determine infection.
For diagnostic tests and imaging to determine infection, see Appendix H.
For description of swabbing technique, see Appendix I.
29
Neuropathy:
Recommendation 2.3:
Identify peripheral neuropathy by assessing for sensory, autonomic and motor (S.A.M.) changes.
(Level of Evidence = II IV)
Discussion of Evidence:
Lavery, Armstrong, Vela, Quebedeau & Fleishchli (1998) noted that patients with only peripheral
neuropathy and no other risk factors were 1.7 times more likely to develop ulceration. Patients with both
neuropathy and foot deformity were 12.1 times more likely to have an ulcer. Patients with neuropathy,
deformity and a history of amputation were 36.4 times likely to develop a foot ulcer.
There are three components to peripheral neuropathy. Listed below are the effects of each form of neuropathy
that the patient with diabetes may present with that will increase the risk of ulcer development:
Component
Pathophysiology
Sensory
Assessment
Autonomic
Sympathetic Denervation
Loss of vasomotor control
Peripheral blood flow
Arteriovenous shunting
Bone blood flow hyperemia
Glycosylation of collagen
Motor
Non-enzymatic glycosylation
Atrophy of intrinsic muscles
of the foot (toe plantar
flexors)
Subluxation of metatarsophalangeal joints
Outcome
Loss of protective
sensation
Sensory ataxia
Falls (15-fold
increase compared
to those without
diabetes)
Anhydrosis
Callus
Fissure cracks
Onychomycosis
(fungal nails)
Peripheral edema
Waxy skin = altered
joint mobility
Claw toes
Hammer toes
Charcot arthropathy
Muscle weakness
Ankle equinus
Pes cavus
Pes planus
Contracture of
Achilles Tendon
*(Apelqvist,1998; Boyko, Ahroni, Stensel, Forsberg, Davignon & Smith, 1999; Bureau of Primary Health Care, 2005; Frykberg,
Lavery, Pham, Harvey, Harkless & Veves, 1998; Lavery, Armstrong, Wunderlich, Tredwell & Boulton; 2003; Shaw & Boulton, 1997).
30
Discussion of Evidence:
Studies have demonstrated that while trauma to a neuropathic foot may be related to a single event, ulcers
frequently occur as a result of repeated minor trauma such as from footwear or elevated pressure on the
bottom of the foot. Foot deformities such as prominent metatarsal heads, clawing of the toes and limited
joint mobility alters the gait or mechanics of walking resulting in abnormal forces on the foot, poor shock
absorption, and shearing and stress to soft tissues (RNAO, 2004; Shaw & Boulton, 1997). People with diabetes
should be assessed regularly to detect foot deformities and should have interventions to reduce foot
pressure and ulcer risk (Australian Centre for Diabetes Strategies, 2001; Royal Melbourne Hospital, 2002).
31
Deformity
32
Deformity
Pes Planus
Pes Cavus
33
Deformity
*Charcot Arthropathy
Above illustrations provided by Nancy A. Bauer, BA, Bus Admin, RN, ET.
* Reference:
Diabetes Nursing Interest Group & Registered Nurses Association of Ontario (2004). Diabetes foot: Risk assessment education
program. Images of the diabetic foot. Registered Nurses Association of Ontario [Electronic version]. Available:
www.rnao.org/bestpractices/PDF/BPG_Foot_Diabetes_Workshop_slides.pdf
34
Gait Abnormality
Gait is the manner or style of walking. The neurodegenerative process is accelerated in diabetes and this
results in a decline in motor control and a pathology-related decline in postural stability/foot posture, and
abnormal weight bearing (Mason OKeefee, McIntosh, Hutchinson, Booth & Young, 1999b; Meier, Desrosiers, Bourassa &
Blaszczyk, 2001). Alterations in gait, balance and mobility are caused by sensory ataxia, poor vision,
debilitation and/or neuropathy in the patient with diabetes (Sinacore & Mueller, 2000). Assessment of gait is
important because patients with diabetes and neuropathy have a 15 times greater risk of experiencing a fall
compared to those without neuropathy (Sinacore & Mueller, 2000).
Some gait patterns that may be observed in a patient with diabetes are: ataxic (unsteady, uncoordinated,
employing a wide base of support), steppage (lift the foot higher to accommodate for foot drop and/or poor
ankle-joint mobility) and antalgic (a limp, usually signifying discomfort).
Foot ulceration has been associated with constant or repetitive pressure from tight shoes over bony
prominences on the dorsum of the lesser toes, at the medial aspect of the first metatarsal head, or the
lateral aspect of the fifth metatarsal (Lavery et al., 1998). In a large prospective study, Abbott, Carrington,
Ashe, Bath, Every, Griffiths et al. (2002) found that the main cause (55%) of ulceration was pressure from
footwear.
In a systematic review of interventions to prevent diabetic foot ulcers, two randomized controlled trials
on patient footwear were reviewed. One study found that type of shoe may be independently important,
and that providing patients with normal well-fitting shoes that distribute abnormal pressures may also
reduce ulcer risk (Mason et al., 1999a). The second study reported that evidence does not support
widespread dispensing of therapeutic shoes and inserts for patients with diabetes and foot deformities.
Patient education may be a more important intervention. However, for those patients unable to be
closely monitored or who have severe deformities, specialized footwear may be beneficial (Reiber, Smith,
Wallace, Sullivan, Hayes, Vath et al. 2002). Maciejewski, Reiber, Smith, Wallace, Hayes & Boyko (2004) reported
results consistent with the second study.
35
Orthotics
Orthotics are custom-made shoe inserts which serve to correct or relieve misalignment and or pressure
areas of the foot. A systematic review was conducted to assess the effectiveness of pressure relieving
interventions in prevention and treatment of diabetic foot ulcers. Spencer (2004) reviewed four
randomized controlled trials of pressure relieving interventions and concluded that in-shoe orthotics
are of benefit.
Diagnostic Tests
Accessability of these tests may be limited to specialty centres.
X-ray
X-rays are useful primarily as imaging tools to identify possible osteomyelitis, foreign bodies, tissue
gas, or bony abnormalities (Royal Melbourne Hospital, 2002).
Pressure Map
Pressure mapping measures foot pressures in standing and walking positions. Lavery et al. (1998)
identified high plantar pressure (65 N/cm2) as a significant factor associated with the presence of foot
ulceration. Pham, Armstrong, Harvey, Harkless, Giurini & Veves (2000) using an F-Scan mat system,
found that foot pressures > 6kg/cm put patients at risk for foot ulcerations.
Discussion of Evidence:
Good record keeping using common language and objective descriptors such as wound measurements
and ulcer grading can increase clarity and may improve outcomes. Careful monitoring of wound healing is
as important as initial assessment and treatment in influencing outcome (Krasner, 1998). At present, there is
a lack of clearly established standards for assessing and documenting wound progress.
Recommendation 3.1:
Identify the location, length, width, depth and classify the ulcer(s). (Level of Evidence = Ia IV)
Discussion of Evidence:
Identification of Ulcer on the Lower Extremity (Level of Evidence = IIa)
Location of a foot ulcer is determined by the site of trauma. In three large prospective studies, 53% of ulcers
involved the toes and 22% involved the first metatarsal area (Apelqvist et al., 2000; Armstrong, Lavery & Harkless,
1998a; Reiber et al., 1999).
36
Recommendation 3.2:
Assess ulcer bed, exudate, odour and peri-ulcer skin. (Level of Evidence = IV)
Discussion of Evidence:
The aim of wound bed assessment is to identify and plan the management of factors that will promote an
optimal healing environment (Vowden & Vowden, 2002). The condition of the periwound area provides
important information about the status of the wound and can influence choice of treatment. Surrounding
skin assessment includes evaluating colour, callus formation, induration, moisture and edema. Redness
can be indicative of unrelieved pressure or prolonged inflammation (Boulton, 1991). When the surrounding
skin has been exposed to moisture for a prolonged period of time, signs of maceration (pale, white or grey
tissue) may be observed. Callus formation is indicative of ongoing pressure to the affected area.
Debridement of callus is generally performed to facilitate accurate assessment of the wound. Induration
(an abnormal firmness of the tissue) and edema are assessed by gently pressing the skin within 4 cm of the wound.
37
Wound exudate characteristics, e.g., type and amount of drainage, provide important information about the
status of the wound. Rating the amount of drainage is useful only if a description of each rating is provided.
Wound is dry = no exudate
Moist wound = scant or small
Wet/saturated = heavy
In addition to amount, the type of exudate should be described.
Serous = clear yellow fluid without blood, pus or debris
Serosanguinous = thin, watery, pale red to pink fluid
Sanguinous = bloody, bright red
Purulent = thick, cloudy, mustard yellow or tan
All wounds, especially those treated with moisture retentive dressings, can emit an odour. Necrotic
wounds tend to have more offensive odour than clean wounds, while wounds infected with anaerobes
tend to produce a distinct acrid or putrid odour. A descriptive odour assessment can provide important
information, as a change in odour may be indicative of an alteration in bacterial balance.
Goals of Care:
Recommendation 4.0:
Define goals based on clinical findings, expert opinion and patient preference. (Level of Evidence = IV)
Recommendation 4.1:
Determine the potential of the ulcer to heal. (Level of Evidence = IV)
Recommendation 4.2:
Develop goals mutually agreed upon by the patient and healthcare professionals.
(Level of Evidence = IV)
Discussion of Evidence:
The perceived value of treating foot ulcers varies from the point of view of the patients and healthcare
professionals. The role of the nurse in the management of patients with a diabetic foot ulcer is to advocate,
collaborate and facilitate the process of goal directed care. The healing potential of a wound must be taken
into consideration. See Figure 2 for factors affecting healing potential.
38
Host
Necrosis
Infection
Environment
Access to care
ESRD
Offloading
Renal transplant
Family support
Microvascular supply
Inflammatory condition
Healthcare sector
Foreign body
Visual impairments
Geographic
Iatrogenic
Glycemic control
Socioeconomic status
Cytotoxic agents
Co-morbidities
Nutrition
PVD
Cultural/personal beliefs
The primary goal in the treatment of diabetic foot ulcers is to obtain wound closure as expeditiously as
possible. The resolution of foot ulcers and decreasing the rate of re-ocurrence can lower the probability of
lower extremity amputation in patients with diabetes.
According to the American Diabetes Association (1999) Consensus Development Conference of Diabetic
Foot Wound Care, foot wounds in patients with diabetes should be treated for several reasons improve
function and quality of life; control infection; maintain health status; prevent amputation; and reduce costs.
Healing of foot wounds improves the appearance of the foot and may allow the patient to return to
ambulation in appropriate footwear. Improving function and return to well-being are important goals of
therapy (ADA, 1999). With impaired mobility, foot wounds often lead to general deconditioning and
psychosocial dysfunction.
Frequent re-evaluation with response-directed treatment is essential. Once the ulcer is closed, the
management of PWDFU should include strategies to decrease the probability of re-ocurrence. Patient
involvement is an essential component of diabetic foot ulcer care, particularly when the encouragement of
adherence, with chronic or complex treatment regimens, is imperative. The care of the patient should be
based on a patient or client centred care approach (See the RNAO guideline [2002a] on Client Centred
Care). Patient-focused care involves a collaborative care planning and interdisciplinary team approach to
assessing, planning, implementing, monitoring and evaluating the care with the patient (Carter, 1995).
Diabetic foot ulcer management in a patient-focused model of care is a holistic approach that offers an
integrated care pathway, identifying the nursing, medical and paramedical activities that must be
synchronized to ensure the patient receives the appropriate treatment from experts of each discipline
(Carter, 1995). Carter (1995) also states that fragmentation of care may lead to conflicting advice for the
patient, and the potential for wastage of time and effort which may lead to protracted wound healing. In a
consumer focus group session led by the development panel, patients who were interviewed consistently
expressed dissatisfaction with limited healthcare expertise and access to specialized services, fragmented
care and long wait times.
39
Management:
This section will discuss the management of diabetic foot ulcers based on a holistic assessment as
discussed in the previous section. The Principles of Management should include:
Vascular management of ischemia and existing co-morbidities
Infection control and removal of necrotic tissue
Plantar pressure offloading intrinsic and extrinsic
The following model assists the clinician in providing a practice framework for treatment of persons with
diabetic foot ulcers (PWDFU).
Debridement
Infection Control
Moisture Balance
Edge of Wound
Biological Agents/
Adjunctive Therapies
Reprinted with permission of Dr. R. G. Sibbald. Adapted from: Sibbald R. G., Orsted, H. L., Schultz, G. S., Coutts, P., & Keast, D. (2003).
Preparing the wound bed 2003: Focus on infection and inflammation. Ostomy/Wound Management, 49(11), 24-51.
40
Recommendation 5.0:
Identify and optimize systemic, local and extrinsic factors that can influence wound healing.
(Level of Evidence = IV)
Discussion of Evidence:
Patients with diabetes often have a combination of complicating factors. These factors maybe categorized as
systemic, local and extrinsic (see Appendix L). Morris, Jones & Harding (2001) indicate that there is no strong
evidence to support that correcting all these factors will necessarily improve wound healing. However, addressing
factors that can be controlled or optimized may increase the potential for healing and quality of life.
Systemic Factors:
Recommendation 5.1:
Modify systemic factors and co-factors that may interfere with or impact on healing.
(Level of Evidence = IV)
Local Factors:
Recommendation 5.2:
Provide local wound care considering debridement, infection control and a moist wound
environment. (Level of Evidence = Ia III)
Discussion of Evidence:
If healing potential is not established, aggressive debridement and moist interactive healing is not
recommended. Wounds that have the greatest potential for healing at an optimal rate require care that
includes:
Debridement
Infection control
Moisture balance
41
Debridement
Infection Control
Moisture Balance
Edge of Wound
Reprinted with permission of Dr. R. G. Sibbald. Adapted from: Sibbald R. G., Orsted, H. L., Schultz, G. S., Coutts, P., & Keast, D. (2003).
Preparing the wound bed 2003: Focus on infection and inflammation. Ostomy/Wound Management, 49(11), 24-51.
Debridement
Although debridement methods vary, common methods of debridement for diabetic foot ulcers include:
Mechanical irrigation with saline solution
Use of autolytic agents (e.g., hydrogels)
Sharp, using a scalpel or scissors (method of choice in an infected wound)
Surgical (occurs in the operating room with anesthesia and surgical instruments)
The frequency of debridement is scheduled at the discretion of the clinician (Inlow et al., 2000).
Callus Reduction
Debridement of callus can significantly reduce pressure at the callus site by approximately 30% (Pitei, Foster
& Edmonds, 1999; Young et al., 1992). Debridement of callus is within the nurses scope of practice, assuming
that the nurse has the knowledge, skill and judgement to perform this procedure.
Tissue Debridement
The removal of nonviable, contaminated and infected tissue from the wound area has been shown to
increase the rate of healing of diabetic foot ulcers (Inlow et al., 2000; Rodeheaver, 2001). In a post-hoc analysis
conducted by Steed, Donohoe, Webster & Lindsley (1996), lower rates of healing were correlated with less
frequent debridement practices. These observations were confirmed in a prospective trial where sharp
debridement may be associated with better outcomes in patients with diabetic foot ulcers (Saap & Falanga, 2002).
Smith (2004) conducted a systematic review to determine the effectiveness of debridement methods for
diabetic foot ulcers. Five randomized controlled trials (RCTs) were identified: three involved the use of
hydrogels and two involved the use of sharp debridement. The results suggest that hydrogels were
significantly more effective than gauze or standard care in healing diabetic foot ulcers. However, sharp
42
debridement has not been shown to be of significant benefit in promoting wound healing. It should be
noted that the clinical trials on sharp debridment are inadequately powered. There is a need for more
research to evaluate the effects of a range of widely used debridement methods and of debridement per se.
Sharp debridement is a high-risk procedure. Debridement with a scalpel should be undertaken
with caution and performed by specially trained and experienced healthcare professionals.
Subcutaneous debridement with a scalpel is a controlled act that must be carried out by a physician
or the delegate. Nurses should be aware of the policies and procedures of their facility.
Infection Control
Infections in a diabetic patient must be treated urgently. Diabetic foot infections can rapidly progress to
limb- or life-threatening situations. The amputation rate in diabetic populations with foot infections has
been reported to range from 12-92% (Tennvall et al., 2000).
Management of diabetic foot ulcer infections should focus on four integrated parameters of care:
Controlling bacterial balance;
Host response/defence;
Complete pressure offloading; and
Local wound care.
According to Peacock and Van Winkle (1976), infection occurs when the number of organisms exceeds the
ability of local tissue defenses to handle them. Maximizing the host ability to fight the infections should be
a major consideration. This includes correction of hyperglycemia, stabilization of other co-morbidities,
good nutrition and rest. Local wound care should include wound cleansing and debridement to remove
devitalized tissue and reduce bacterial load in the wound (Saap & Falanga, 2002; Steed et al., 1996).
Antimicrobial management of diabetic foot infection should be based on the Ontario Anti-infective Guidelines
for Community Acquired Infections (Ontario Anti-infective Review Panel, 2001). The prescribed antibiotic(s) should
be based on the results of the culture and sensitivity of the organism(s) in conjunction with the physicians
clinical judgement.
Once a treatment plan is developed and initiated, an evaluation period should be established to determine
the patients response to treatment.
Application of moisture retentive dressings in the context of ischemia and or dry gangrene
can result in a serious life- or limb-threating infection.
See Table 3 for Treatment of Infection.
43
Limb-threatening infection
Systemic infection
As in superficial infection
Polymicrobial
May be monomicrobial
Topical antimicrobials
Consider hospitalization
Consider Infectious Disease consultation
Ongoing evaluation based
Offloading
Bedrest
on clinical findings
on clinical findings
Patient education
A. Non-Limb-Threatening Infections
Ulceration does not need to be present since non-limb-threatening infections can result from small
puncture wounds, scratches, nail trauma or heel (fissure) cracks. Mild to moderate infection can usually be
managed on an outpatient basis with close supervision by the medical practitioner. Topical antimicrobials
can be used to reduce bacterial burden in superficial infections. There are several iodine and silver preparations
now available that are safe, effective and economical (Sibbald et al., 2003). Systemic antibiotics may be prescribed
by the physician or the Registered Nurse/Extended Class (RN/EC) in the community. See Appendix M for
a list of Topical Antimicrobial Agents.
If the wound still fails to heal and there is evidence of increased superficial bacterial burden or delayed
healing with no evidence of deep infection, use local antimicrobials with debridement and moisture
balance. If there is evidence of deep infection, or if the wound fails to demonstrate signs of healing within
two weeks with topical antimicrobials, systemic antibiotics may be considered.
B. Limb-Threatening Infections
Diabetic foot infections in this category may have cellulitis that extends greater than 2 cm beyond the
wound border including cardinal signs of infections such as fever, edema, lymphangitis, hyperglycemia,
leukocytosis, and/or ischemia (Frykberg et al., 2000). An ulcer that probes to the bone or joint is highly
predictive of osteomyelitis (Grayson et al., 1995). Since the patient with diabetes with a relatively severe
infection may not necessarily present with these signs and symptoms, it is important to review the entire
clinical assessment to guide the clinician to the proper course of treatment. A patient presenting with wet
gangrene, deep abscesses, and advancing cellulitis must be transferred to a medical facility for urgent care.
Hospitalization is required in order to treat the infection as well as the systemic sequelae. Patients with
poor vascular status and deep infections may require vascular surgery and infectious disease consultation.
Urgent surgical intervention may be required. Although many wound drainage procedures can be done at
the bedside for patients with diabetic ulcers, most will require thorough debridement in the operating
room (Frykberg et al., 2000). Even the sickest of patients should be considered for emergent incision, drainage,
44
and debridement procedures since their illness is directly attributable to the severity of their infection. Lifethreatening infections necessitate immediate surgical attention and such procedures should not be
delayed while waiting for radiologic or medical workup of other co-morbid conditions (Frykberg et al., 2000).
Polymicrobial infection should be anticipated in patients with a diabetic foot ulcer, with a variety of grampositive cocci, gram-negative rods, and anaerobic organisms predominating. Empirical antibiotic therapy
typically includes broad-spectrum coverage for more common isolates from each of these three categories
(Frykberg et al., 2000). Once wound culture results have been obtained, the initial antimicrobial therapy may
require adjustment to provide more specific coverage or to provide therapy against resistant organisms. If
there is persistent infection while on antibiotic therapy, surgical assessment and wound culture should be
revisited. Methicillin-resistant staphylococci aureus (MRSA) has been emerging as an important pathogen
in chronic diabetic foot ulcers (Frykberg et al., 2000).
C. Osteomyelitis
Osteomyelitis and joint infection will require excision of bone for microbiological and histopathological
evaluation (Frykberg et al., 2000). If the affected bone has been completely resected or amputated, the infection
may be treated as a soft-tissue infection. However, if residual bone is present in the wound, the patient will
likely require 4-8 weeks of antibiotic therapy based on the culture results (Frykberg et al., 2000). Intravenous
or oral agents may be used, depending on the microbial isolates and the infection severity.
Moisture Balance
Dressing selection should promote a moist wound environment that minimizes trauma and risk of
infection. Selection should be based on the wound to provide local moisture balance. Modern, moist
interactive dressings used for diabetic foot ulcers include foams (high absorbency), calcium alginates
(absorbent, hemostasis), hydrogels (moisture balance), hydrocolloids (occlusion), and adhesive
membranes (protection) (Inlow et al., 2000). Consideration should be given to the following when choosing a
moist wound dressing for a diabetic foot ulcer (Sibbald, Williamson, Orsted, Campbell, Keast, Krasner et al., 2000):
Assess the wound bed for bacterial balance, exudate level and the need for debridement.
Select a dressing or combination of dressings that can manage and or control the above wound
environment.
Use a dressing that will keep the wound bed continuously moist and the peri-wound skin dry.
Choose a dressing that controls exudate but does not dry the ulcer bed.
Consider the caregiver time when selecting a dressing.
Eliminate wound dead space by loosely filling all cavities with dressing material.
Assure that the patient is aware that there is to be reduced pressure to the affected area.
Evaluate the wound frequently to determine efficacy of treatment plan.
Systematic reviews in the past have shown no differences in chronic wound healing outcomes (Hutchinson et
al., 2000; Ovington, 1999). However, in a recent systematic review by Smith (2004), hydrogels were shown to be
of some benefit in improving diabetic foot ulcers. Consideration of caregiver time is essential to cost
efficency (Ovington, 1999). For information on dressing selection see Appendix N.
45
Extrinsic Factors
Recommendation 5.3:
Provide pressure redistribution. (Level of Evidence = IIa )
Discussion of Evidence:
Ninety four percent of diabetic foot ulcers occur at areas of increased pressure (Fleischli, Lavery, Vela, Ashry & Lavery, 1997).
Elevated plantar pressures coupled with neuropathy (lack of sensation) can lead to callus formation. The
callus build-up (hyperkeratosis) is a normal response to the stress of elevated pressures on the foot and if
untreated leads to ulcer formation. For a diabetic foot ulcer to heal the repetitive pressure must be reduced.
This can be accomplished by the application of a number of external devices. It is important that there is a
member of the team skilled in the fabrication and modification of offloading devices, such as a foot care
specialist. See Appendix O for examples and considerations in selecting offloading devices.
One randomized controlled trial showed that total contact casting (TCC) was effective in treating well
vascularized non-infected plantar forefoot diabetic foot wounds. Healing rates range from 72% to 100%
over a course of five to seven weeks (Armstrong, Nguyen, Lavery, van Schie, Boulton & Harkless, 2001). Spencer (2004)
conducted a systematic review evaluating the effectiveness of various offloading modalities to treat
diabetic foot ulcers. One randomized controlled trial on total contact casting was identified showing weak
evidence on its effectiveness in the treatment of diabetic foot ulcers.
It is important that the patient with a diabetic foot ulcer recognizes that pressure is the cause of their foot
ulcer and the offloading is required whenever they are on their feet. In a study by Armstrong, Lavery,
Kimbriel, Nixon and Boulton (2003) describing adherence to offloading devices, subjects were found to be
only 25% compliant with their prescribed device.
Discussion of Evidence:
While complete wound closure is widely accepted to be an objective endpoint in wound healing, this may
not always be appropriate in assessing outcomes in chronic wounds (Enoch & Price, 2004). There are various
factors that can contribute to the chronicity of such wounds.
46
Using a topical, cost effective and potentially cytotoxic antiseptic such as povidine iodine can be
considered when the risk of infection outweighs the healing potential.
Evaluation:
Recommendation 6.0:
Evaluate the impact and effectiveness of the treatment plan. (Level of Evidence = IV)
Discussion of Evidence:
Assuming that all systemic and local factors have been addressed, Sheehan, Jones, Caselli, Giurini & Veves
(2003) have shown that a 50% reduction in wound surface area at four weeks is a good predictor of wound
healing at 12 weeks. Furthermore, Flanagan (2003) has shown that a 20% 40% reduction of wound area in
two and four weeks is likely to be a reliable predictive indicator of healing.
47
Assessment of the edge of the wound will determine if cell migration has begun. According to Schultz,
Barillo, Mozingo, Chin & The Wound Bed Advisory Board Members (2004), wound proliferation occurs
when keratinocytes and responsive wound cells migrate; thus advancing the edge of the wound. Healthy
wounds have a pink wound bed and an advancing wound margin while unhealthy wounds have a dark,
friable wound bed and an undermined wound margin.
Reassess:
It should not be expected that all diabetic foot ulcers will have closure of the wound as a primary outcome.
Wounds that are unlikely to heal need to have alternative outcome expectations such as wound
stabilization, reduced pain, reduced bacterial load and decreased dressing changes (Enoch & Price, 2004).
Ongoing wound assessment should be comprehensive and support the rationale for care. The guideline
development panel suggests these questions below as an approach to evaluating outcomes of care.
1. Is the treatment plan effective?
2. How is wound healing evaluated?
3. Is wound closure the only successful wound care outcome?
Recommendation 6.1:
Reassess for additional correctable factors if healing does not occur at the expected rate.
(Level of Evidence = III IV)
Discussion of Evidence:
Reassessment of the entire treatment program is the first step to establishing a new directed approach.
The most common reason for delayed healing in PWDFU is inadequate pressure offloading. If appropriate
offloading is not prescribed, the patient should be referred to a centre specializing in diabetic foot ulcer care.
Revisiting adherence to prescribed offloading devices may uncover the reason why the wound is not healing
(Armstrong et al., 2003).
Infection should always be considered as a possible cause of non-healing in combination with glycemic
control. Revisiting the health history, co-morbidities and overall diabetes management may maximize the
desired outcome.
If patient and wound are optimized and edge is still not migrating, consider tissue culture, biopsy and other
diagnostic tests to rule out other conditions.
If delayed healing occurs, continuously evaluate. Vascular, infection and pressure parameters can change
quickly; frequent monitoring for change in status or parameters is required. See Table 3 for treatment of
wound infection in Recommendation 5.2.
If healing is still delayed, adjunctive approaches should be considered. See Recommendation 6.2.
48
Other Therapies
Recommendation 6.2:
Consider the use of biological agents, adjunctive therapies and/or surgery if healing has not occurred
at the expected rate. Review each specific modality for recommendations. (Level of Evidence = 1a IV)
Discussion of Evidence:
Care for diabetic foot ulcers that have not healed at the expected rate may include the use of:
Biological agents
Adjunctive therapies
Surgery (e.g., skin graft, Achilles tendon lengthening, bony reconstruction)
Electrical Stimulation
Evidence:
A meta analysis (Foster, Smith, Taylor, Zinkie & Houghton, 2004) of 17 RCTs
showed that electrical stimulation was effective in treating chronic
wounds (p< 0.0001), included in this analysis were 3 RCTs with patients
with diabetic foot ulcers (Baker, Chambers, DeMuth & Villar, 1997; Lundeberg,
Eriksson & Malm, 1992; Peters, Lavery, Armstrong & Fleischli, 2001).
(Level of Evidence = 1a)
Hyperbaric Oxygen
Therapy (HBOT)
Evidence:
The routine management of diabetic foot ulcers with HBOT is not
justified by the evidence found in the systematic review conducted by
Kranke, Bennett & Roeckl-Wiedmann (2004). Although HBOT significantly
reduced the risk of major amputation and may improve the chance of
healing at one year, economic evaluations should be undertaken. With
methodological shortcomings and poor reporting of the studies that
were reviewed, Kranke et al. (2004) cautions that any benefit from HBOT
will need to be examined further using rigorous randomized trials.
(Level of Evidence = III)
49
Evidence:
The two small trials that evaluated the effectiveness of TNP on chronic
wound healing provide weak evidence suggesting that TNP may be
superior to saline gauze dressings in healing chronic human wounds.
Findings: Due to the small sample sizes and methodological limitations
of these trials, there is weak evidence to date.
The effect of TNP on cost, quality of life, pain and comfort was not
reported. It was not possible to determine which was the optimum TNP
regimen (Armstrong, Lavery, Abu-Rumman, Espensen, Vazquez, Nixon et al., 2002;
Ballard & McGregor, 2001; Clare, Fitzgibbons, McMullen, Stice, Hayes & Henkel, 2002;
McCallon, Knight, Valiulus, Cunningham, McCulloch & Farinas, 2000; Sibbald,
Mahoney & VAC Therapy Canadian Consensus Group, 2003).
Biological Agents
Growth Factors
Evidence:
Four multicentre, randomized paralled group studies found that once-daily
topical administration of becaplermin gel in conjuction with good ulcer
care was effective and well tolerated in patients with full-thickness,
lower extremity diabetic ulcers (Smiell, Wieman, Steed, Perry, Sampson &
Schwab, 1999). (Level of Evidence = 1b
50
Biological Agents
Bioactive Agents
et al., 1999; Marston, Hanft, Norwood & Pollak, 2003) (Level of Evidence = 1b)
Oasis, Promogran and Hyalofil are examples of acellular bioactive agents.
Oasis is a freeze dried wound matrix derived from porcine (pig)
small intestinal submucousa (Brown-Etris, Cutshall & Hiles, 2002).
Xenograft: Oasis, a relatively new product, is a xenogeneic, acellular,
collagen matrix derived from porcine small intestinal submucosa in
a way that allows extracellular matrix and natural growth factors to
remain intact. This provides a scaffold for inducing wound healing.
Evidence:
In a small multicentre clinical study evaluating the efficacy of Oasis
compared to Regranex, Niezgoda (2004) found similar wound healing
outcomes in both treatment groups. (Level of Evidence = IIa)
Evidence:
One RCT comparing Promogran to moistened gauze dressings showed
that at 12 weeks, no statistical differences were found in the healing rates
between the two groups (Veves, Sheehan & Pham, 2002). Ghatnekar, Willis &
Persson (2002) suggest that Promogran may be cost effective as a result
of reduced dressing frequency. (Level of Evidence = Ib)
51
Surgery
Surgical
(Skin Graft Autologous)
Surgical
(Achilles tendon lengthening)
Evidence:
Mueller et al. (2004) compared the effect of Achilles tendon lengthening
to treatment with total contact casting. The outcomes measured were
healing rates and ulcer re-occurrence at seven-months follow up and
two-year follow up. Although the initial wound healing outcomes were
similar, statistical reduction in ulcer re-occurrence was noted at sevenmonths and at two-years follow up.
Education Recommendations
Continuing Professional Development:
Recommendation 7.0:
Nurses and other members of the interdisciplinary team need specific knowledge and skills in
order to competently assess and participate in the treatment of diabetic foot ulcers.
(Level of Evidence = IV)
52
Discussion of Evidence:
Nurses play a vital role in the early detection and ongoing assessment of diabetic foot ulcers. They are also
in a pivotal position to facilitate an evidence-based, team approach to treatment (Mason et al., 1999a;
Whittemore, 2000). If nurses are to fulfill these roles, they must utilize the nursing process and evidence to
support patient care decisions. Nurses need to avail themselves of recognized, accredited continuing
educational opportunities that support the interdisciplinary team approach to diabetic foot ulcer care. In
order to improve health outcomes for persons with diabetic foot ulcers and increase job satisfaction for
nurses, agencies need to provide a full scope of support (financial, education, and human resources) for
nurses seeking professional education (Best & Thurston., 2004; Gottrup, 2004).
Refer to Appendix P for a list of resources for diabetic foot ulcer information.
Resources:
Recommendation 9.1:
Organizations are encouraged to develop policies that acknowledge and designate human, material
and fiscal resources to support the nurse and the interdisciplinary team in diabetic foot ulcer
management. (Level of Evidence = IV)
53
Team Development:
Recommendation 9.2:
Organizations are encouraged to establish and support an interdisciplinary, inter-agency team
comprised of interested and knowledgeable persons to address and monitor quality improvement
in the management of diabetic foot ulcers. (Level of Evidence = IV)
Partnerships:
Recommendation 9.3:
Organizations are encouraged to work with community and other partners to develop a process to
facilitate patient referral and access to local diabetes resources and health professionals with
specialized knowledge in diabetic foot ulcer management. (Level of Evidence = IV)
Financial Support:
Recommendation 9.4:
Organizations are encouraged to advocate for strategies and funding to assist patients in obtaining
appropriate pressure redistribution devices. (Level of Evidence = IV)
Advocacy:
Recommendation 9.5:
Organizations are encouraged to advocate for an increase in the availability and accessibility of
diabetic foot ulcer care for all residents of Ontario. (Level of Evidence = IV)
Discussion of Evidence:
In order to achieve optimal outcomes for individuals with diabetic foot ulcers, diabetes ulcer care should
be platformed around an interdisciplinary healthcare team that can establish and sustain a communication
network between the person with diabetes and the necessary healthcare and community systems.
Frykberg (1998), through a retrospective review of the literature reported a reduction in non-traumatic
amputation rates ranging from 58% to 100% after the implementation of a multidisciplinary approach to
foot care. The team should be dedicated to both maintaining the overall well-being of the patient with
diabetes and to preserving the integrity of their lower extremities (Inlow et al., 2000). Key players on the team,
along with patients and families, may include diabetologists/endocrinologists, vascular surgeons, plastic
surgeons, dermatologists, chiropodists/podiatrists, infectious disease specialists, family physicians, nurses
specializing in diabetes and wound care, occupational therapists, physiotherapists, and dietitians. Teams
can work without walls (not necessarily on the same site, but accessible to each other). However,
coordination takes more effort to ensure the goal(s) remain consistent (Inlow et al., 2000). Both the
organization and the delivery of diabetes foot care should be comprehensive, supported by evidence-based
clinical practice guidelines, and equitable in access throughout the persons lifetime. Diabetes foot ulcer
care should be community based and respectful of age, gender, cultural beliefs and socioeconomic
dispositions. Organizations have a role to play in advocating and facilitating access to diabetes care and
foot ulcer care services.
54
Graham, Harrison, Bouwers, Davies & Dunn (2002) indicate that in order for guidelines to be implemented
successfully, a critical initial step must be the formal adoption of the guideline recommendations into the
policy and procedure structure. This key step provides direction regarding the expectations of the
organization, and facilitates integration of the guideline into such systems as the quality management process.
New initiatives such as the implementation of a best practice guideline require strong leadership from nurses
who understand concepts of planned change, program planning and evaluation and research utilization.
This knowledge will empower the nurse to effectively transform organizations in changing practice. This
can be achieved by developing a program plan. Pollack (1994) developed a four-step planning process
called pre-start plan. The process includes mission statement clarification, stakeholder analysis, problem
identification, and strength, weakness, opportunities and threats (SWOT) analysis.
Further, it is suggested that the RNAO Toolkit (2002b) be considered to assist organizations develop the
leadership required for successful implementation. Refer to Appendix Q for a description of the RNAO
Toolkit: Implementation of Clinical Practice Guidelines.
Establishment of a standardized assessment and documentation tools for diabetic foot ulcers.
Dressing choices for local wound care.
Effectiveness of adjunctive therapies to promote wound healing.
Effectiveness of various devices utilized for pressure redistribution/offloading.
Health delivery issues (government support and funding of programs and treatment for diabetic foot
ulcer management, cultural beliefs, high risk patient populations).
Impact of sharp/surgical debridement on wound healing.
Impact of education on healthcare provider and specific patient outcomes (ulcer healing/re-occurrence).
Pharmacoeconomics of secondary and tertiary prevention strategies.
The above list, although in no way exhaustive, is an attempt to identify and prioritize the enormous
amount of research that is needed in this area. Some of the recommendations in the guideline are based
on evidence gained from quantitative and qualitative research. Other recommendations are based on
consensus or expert opinion. Further substantive research is required to validate the expert opinion.
Increasing the research can impact knowledge that will lead to improved practice and outcomes for
patients who experience diabetic foot ulcers.
55
Structure
Process
Outcome
Objectives
Organization/
Unit
Availability of patient
education resources that are
consistent with best
practice recommendations.
Development of forms or
documentation systems
that encourage
documentation of
assessment and
management of diabetic
foot ulcers.
Provider
Provision of accessible
resource people for nurses
and the interdisciplinary
team to consult for ongoing
support during and after
initial implementation
period.
Percentage of healthcare
providers attending the best
practice guideline
education sessions on
assessment
and management of diabetic
foot ulcers.
Self-assessed knowledge of
assessment and
management of diabetic
foot ulcers.
Average self-reported
awareness levels of
community referral
sources for patients with
diabetic foot ulcers.
56
Level of
Indicator
Patient
Structure
(new or
recurrent
diabetic
foot ulcer)
Financial
Costs
Percentage of patients
admitted to unit/facility or
seen at the clinic with
diabetic foot ulcers.
Provision of adequate
financial resources for the
level of staffing necessary to
implement guideline
recommendations.
Process
57
Outcome
Implementation Strategies
The Registered Nurses Association of Ontario and the guideline development panel have
compiled a list of implementation strategies to assist healthcare organizations or healthcare disciplines
who are interested in implementing this guideline. A summary of these strategies follows:
Have at least one dedicated person such as an advanced practice nurse or a clinical resource nurse
who will provide support, clinical expertise and leadership. The individual should also have good
interpersonal, facilitation and project management skills.
Conduct an organizational needs assessment related to diabetic foot ulcer management to identify
current knowledge base and further educational requirements.
Initial needs assessment may include an analysis approach, survey and questionnaire, group format
approaches (e.g., focus groups), and critical incidents.
Create a vision to help direct the change effort and develop strategies for achieving and sustaining
the vision.
Design educational sessions and ongoing support for implementation. The education sessions may
consist of presentations, faciltators guide, handouts, and case studies. Binders, posters and pocket
cards may be used as ongoing reminders of the training. Plan education sessions that are interactive,
include problem solving, address issues of immediate concern and offer opportunities to practice new
skills (Davies & Edwards, 2004).
58
Provide organizational support such as having the structures in place to facilitate the implementation.
For example, hiring replacement staff so participants will not be distracted by concerns about work
and having an organizational philosophy that reflects the value of best practices through policies and
procedures. Develop new assessment and documentation tools (Davies & Edwards, 2004).
Identify and support designated best practice champions on each unit to promote and support
implementation. Celebrate milestones and achievements, acknowledging work well done (Davies &
Edwards, 2004).
Organizations implementing this guideline should adopt a range of self-learning, group learning,
mentorship and reinforcement strategies that will, over time, build the knowledge and confidence of
nurses in implementing this guideline.
Beyond skilled nurses, the infrastructure required to implement this guideline includes access to
specialized equipment and treatment materials. Orientation of the staff to the use of specific products
and technologies must be provided and regular refresher training planned.
Teamwork, collaborative assessment and treatment planning with the patient and family and
interdisciplinary team are beneficial in implementing guidelines successfully. Referral should be
made as necessary to the following services or resources in the community or within the organization:
Chiropodist, Wound Care Clinic, Diabetes Education Centre, Nurses specializing in wound and
diabetes care; Dermatologist, Infectious Disease Specialist, Vascular Surgeon, Plastic Surgeon, and
other healthcare professionals who provide care to patients with diabetic foot ulcers such as Family
Physician, Dietitian, Occupational Therapist and Physiotherapist.
The RNAOs Advanced/Clinical Practice Fellowships (ACPF) Project is another resource that registered
nurses in Ontario may apply for a fellowship and have an opportunity to work with a mentor who has
expertise in diabetic foot ulcer management. With the ACPF, the nurse fellow will have the opportunity
to hone their skills in assessing and managing diabetic foot ulcers.
In addition to the strategies mentioned above, the RNAO has developed resources that are available on
their website. A Toolkit for implementing guidelines can be helpful if used appropriately. A brief
description about this Toolkit can be found in Appendix R. A full version of the document in pdf format is
also available at the RNAO website, www.rnao.org/bestpractices.
59
60
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Abbott, C. A., Carrington, A. L., Ashe, H., Bath, S., Every, L. C., Griffiths, J. et al. (2002). The North-West Diabetes Foot Care Study:
Incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabetes Medicine, 19 377-384.
Abouaesha, F., van Schie, C. H., Griffiths, G. D., Young, R. J., & Boulton, A. J. (2001). Plantar tissue thickness is related to peak
plantar pressure in the high-risk diabetic foot. Diabetes Care, 24(7), 1270-1274.
Adler, A. I., Boyko, E. J., Ahroni, J. H., & Smith, D. G. (1999). Lower-extremity amputation in diabetes: The independent effects
of peripheral vascular disease, sensory neuropathy, and foot ulcers. Diabetes Care, 22(7), 1029-1037.
Adler, A. I., Stratton, I. M., Neil, H. A. W., Yudkin, J. S., Matthews, D. R., Cull, C. A. et al. (2000). Association of systolic blood
pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): Prospective observational study.
British Medical Journal, 321 412-419.
AGREE Collaboration (2001). Appraisal of guidelines for research and evaluation. AGREE Collaboration [Electronic version].
Available: http://www.agreecollaboration.org/
Alderson, P., Green, S., & Higgins, J. (Eds) (2004). Cochrane Reviewers Handbook 4.2.2 (updated Dec. 2003). [Electronic
version]. Available: http://www.cochrane.org/resources/handbook/
American Association of Diabetes Educators (1999). The 1999 scope of practice for diabetes educators and the standards of
practice for diabetes educators. American Association of Diabetes Educators [Electronic version]. Available: http://www.aadenet.org
American Diabetes Association (ADA) (1999). Consensus development conference on diabetic foot wound care. Ostomy/Wound
Management, 45(9), 2-47.
American Diabetes Association (ADA) (2001). American Diabetes Association: Clinical practice recommendations 2001.
Diabetes Care, 24(Suppl 1), S1-S133.
Apelqvist, J. (1998). Wound healing in diabetes Outcome and costs. Clinics in Podiatric Medicine and Surgery, 15(1), 21-39.
Apelqvist, J., Bakker, K., van Houtum, W. H., Nabuurs-Franssen, M. H., & Schaper, N. C. (2000). International consensus and practical
guidelines on the management and the prevention of the diabetic foot. Diabetes/Metabolism Research and Reviews, 16(Suppl 1), S84-S92.
Apelqvist, J., Castenfors, J., Larsson, J., Stenstrm, A., & Agardh, C.-D. (1989). Prognostic value of systolic ankle and toe blood
pressure levels in outcome of diabetic foot ulcer. Diabetes Care, 12(6), 373-378.
Armstrong, D. G. & Lavery, L. A. (1998a). Evidence-based options for offloading diabetic wounds. Clinics in Podiatric Medicine
and Surgery, 15(1), 95-105.
Armstrong, D. G., Lavery, L. A., Abu-Rumman, P., Espensen, H., Vazquez, R., Nixon, B. P. et al. (2002). Outcomes of subatmospheric
pressure dressing therapy on wounds of the diabetic foot. Ostomy/Wound Management, 48(4), 64-68.
Armstrong, D. G., Lavery, L. A., & Bushman, T. R. (1998). Peak foot pressures influence the healing time of diabetic foot ulcers
treated with total contact casts. Journal of Rehabilitation Research and Development, 35(1), 1-5.
Armstrong, D. G., Lavery, L. A., & Harkless, L. B. (1998a). Who is at risk of diabetic foot ulceration? Clinics in Podiatric Medicine
and Surgery, 15(1), 11-19.
Armstrong, D. G., Lavery, L. A., & Harkless, L. B. (1998b). Validation of a diabetic wound classification system: The contribution
of depth, infection, and ischemia to risk of amputation. Diabetes Care, 21(5), 855-859.
Armstrong, D. G., Lavery, L. A., Kimbriel, H. R., Nixon, B. P., & Boulton, A. J. (2003). Activity patterns of patients with diabetic foot
ulceration: Patients with active ulceration may not adhere to a standard pressure offloading regimen. Diabetes Care, 26(9), 2595-2597.
Armstrong, D. G., Lavery, L. A., Sariaya, M., & Ashry, H. (1996). Leukocytosis is a poor indicator of acute osteomyelitis
of the foot in diabetes mellitus. The Journal of Foot and Ankle Surgery, 35(4), 280-283.
Armstrong, D. G., Nguyen, H. C., Lavery, L. A., van Schie, C. H. M., Boulton, A. J. M., & Harkless, L. B. (2001). Offloading the
diabetic foot wound: A randomized clinical trial. Diabetes Care, 24(6), 1019-1022.
Armstrong, D. G., van Schie, C. H. M., & Boulton, A. J. M. (2001). Offloading foot wounds in people with diabetes. In D. L. Krasner,
G. T. Rodeheaver, & R. G. Sibbald (Eds.), Chronic wound care: A clinical source book for healthcare professionals. (3rd ed.).
Wayne, PA: HMP Communications.
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Apelqvist, J. & Larsson, J. (2000). What is the most effective way to reduce incidence of amputation in the diabetic foot?
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treatment alternatives and strategies. Diabetic Medicine, 12 123-128.
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Armstrong, D. G. & Athanasiou, K. A. (1998). The edge effect: How and why wounds grow in size and depth. Clinics in
Podiatric Medicine and Surgery, 15(1), 105-108.
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Physician, 57(6), 1325-1332-1337-1338.
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Diabetes [Electronic version]. Available: http://www.diabetic-foot.net/id51.htm
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76
The final step in determining whether the clinical practice guideline would be critically appraised was to
have two individuals screen the guidelines based on the following criteria. These criteria were determined
by panel consensus:
Guideline was in English, international in scope.
Guideline dated no earlier than 1997.
Guideline was strictly about the topic area.
Guideline was evidence-based, (e.g. contained references, description of evidence, sources of evidence).
Guideline was available and accessible for retrieval.
77
Abscess: A
Anhydrosis: Failure of the sweat glands to produce sweat, resulting in dryness in the skin, often a
result of damaged nerves or neuropathy.
Antibiotic: An agent that is synthesized from a living organism (e.g., penicillin from mold ) and can
kill or halt the growth of microbes or bacteria.
Antimicrobial: An agent that is used to kill bacteria or microbes, that is not synthesized from a
living organism (e.g., iodine or silver).
Antiseptic (Topical):
Callus: An area of skin that is abnormally thick or hard, usually from continual pressure or friction,
sometimes over a bony prominence.
Cellulitis: An infection of the skin characterized most commonly by local heat, redness (erythema),
pain and swelling.
Edge of Wound: It is an important part of the algorithm for wound management in diabetic foot
ulcers. It provides an outcome statement (goal of care), provides structure for care (enabler), and it
supports the use of a common language to determine healing (links practitioners). It determines if
cell migration has begun.
78
Exuberant Granulation Tissue: New granulation tissue that is proliferating above the normal rate.
Fissures: A long, narrow opening or gap that can extend into other cavities or areas of the body.
Friable Tissue: Granulation tissue that bleeds easily with minimal stimulation. Normal healthy
tissue is not friable.
F-Scan mat:
Infection:
Local Clinical Infection. A clinical infection that is confined to the wound and within a few
millimeters of its margins e.g., purulent exudate, odour, erythema, warmth, tenderness,
edema, pain, fever, and elevated white cell count.
Systemic Clinical Infection. A clinical infection that extends beyond the margins of the wound.
Some systemic infectious complications of pressure ulcers include cellulitis, advancing
cellulitis, osteomyelitis, meningitis, endocarditis, septic arthritis, bacteremia, and sepsis.
Insensate: A word that describes a region of the body where the person cannot feel a stimulus. An
example is when a monofilament is applied using proper technique, if the person does not feel the
filament, that area of the foot is described as insensate.
Malnutrition:
Metatarsal Heads: The metatarsal region of the foot is the area on the bottom of a foot just
before the toes, more commonly referred to as the ball-of-the-foot.
MRSA:
79
Onychomycosis:
Fungal infection in the toe nails. Nails may appear dry, thickened, white or
Pallor: White, pale, blanched colour of a limb when in the upright position.
Pes Cavus: A foot characterized by an abnormally high arch. Hyperextension of the toes may be
present which can give the foot the appearance of a claw.
Pes Planus: A foot that has a fallen arch and appears abnormally flat or spread out.
Photoplethysmography: Photoplethysmography uses infra-red light to assess changes in the
blood volume in the micro-circulation.
Rubor: Dark purple to bright red colour of a limb when in a dependent position.
Sensory Ataxia: Is an impairment of ones sense of body position. It may be characterized by
striking the ground forcibly with the bottom of the foot as well as a stiff fling of the leg with walking.
Specificity: The chance of having a negative test result given that one does not have a disease.
Sensitivity: The chance of having positive test result given that one does have a disease.
Toe Pressure: See photoplethysmography.
80
Appendix C:
University of Texas Foot Classification System
Categories 0-3: Risk Factors for Ulceration
Category 0: No Pathology
No history of ulceration
No history of ulceration
No foot deformity
Patient education
Copyright 1997 by D.G. Armstrong, L.A. Lavery, L.B. Harkless. Reprinted with permission of Dr. D. G. Armstrong.
81
Appendix D:
University of Texas Foot Classification System
Categories 4-6: Risk Factors for Amputation
Category 4A: Neuropathic Wound
Infected wound
Medical management
82
Appendix E:
University of Texas Health Science Center
San Antonio Diabetic Wound Classification System
GRADES
0
II
III
Superficial wound,
not involving tendon,
capsule, or bone
Wound penetrating
to tendon or capsule
Wound penetrating
to bone or joint
Pre- or post-ulcerative
lesion, completely
epithelialized with
infection
Wound penetrating
to tendon or capsule
with infection
Wound penetrating
to bone or joint with
infection
Pre- or post-ulcerative
lesion, completely
epithelialized with
ischemia
Wound penetrating
to tendon or capsule
with ischemia
Wound penetrating
to bone or joint with
ischemia
Pre- or post-ulcerative
lesion, completely
epithelialized with
infection and ischemia
Wound penetrating to
tendon or capsule with
infection and ischemia
Wound penetrating to
bone or joint with
infection and ischemia
83
Appendix F:
Diabetic Foot Care Patient Handout
Any healthcare team member can assess the patient and/or caregivers knowledge regarding their foot care.
This patient handout was designed to assist team members in reviewing basic foot care strategies. Each
item is explained in details on p.84 while p.85 is an easy to use checklist that encourages the patient to
check each important aspect of care, using a simple check mark in each box. The make notes section is
intended to remind patients to discuss any changes or questions with their healthcare provider.
Reprinted with permission: Laurie Goodman, RN, BA, IIWCC, Nurse Clinician, Skin & Wound Care, Credit Valley Hospital.
84
Reprinted with permission: Laurie Goodman, RN, BA, IIWCC, Nurse Clinician, Skin & Wound Care, Credit Valley Hospital.
85
Appendix G:
Diagnostic Tests to Determine Vascular Supply
Diagnostic Test
Description
Arterial
Duplex Scan
Transcutaneous
Oxygen (TcpO2)
Systolic toe and ankle pressures are measured with a fitted occluding cuff
placed most often around the base of the first toe and around both ankles.
Toe pressure of >45 mmHg is necessary for optimal healing (Apelqvist, Castenfors,
Larsson, Stenstrm & Agardh, 1989; Frykberg et al., 2000).
Most patients with toe blood pressures >30mmHg healed with conservative
management (Apelqvist et al., 1989; Kalani, Brismar, Fagrell, Ostergren & Jorneskog, 1999;
Royal Melbourne Hospital, 2002).
With ankle pressures > 80 mmHg, most patients had an amputation or died
before healing occurred (Apelqvis et al., 1989).
Kalani et al. (1999) suggests a cut-off of 25mmHg for TcpO2 and 30mmHg for
toe blood pressure as predictors of wound healing, with TcpO2 being the
better predictor in patients with diabetes and chronic foot ulcers. Toe
pressures, however, may be more technically and economically feasible.
Ankle-Brachial
Pressure Index
(ABPI)
ABPI or ratio of systolic blood pressure in the lower extremity to blood pressure
in the arm is a common clinical measure of reduced circulation (Boyko et al., 1999).
Caution:
This should not be the sole diagnostic test performed.
In patients with diabetes, ABPI results can be unreliable (falsely negative)
due to calcification of the arterial vessels (Apelqvist et al., 1989).
86
References:
Adler, A. I., Boyko, E. J., Ahroni, J. H., & Smith, D. G. (1999). Lower-extremity amputation in diabetes:
The independent effects of peripheral vascular disease, sensory neuropathy, and foot ulcers. Diabetes Care, 22(7), 1029-1037.
Apelqvist, J., Castenfors, J., Larsson, J., Stenstrm, A., & Agardh, C.-D. (1989). Prognostic value of systolic ankle
and toe blood pressure levels in outcome of diabetic foot ulcer. Diabetes Care, 12(6), 373-378.
Ballard, J. L., Eke, C. C., Bunt, T. J., & Killeen, J. D. (1995). A prospective evaluation of transcutaneous oxygen measurements
in the management of diabetic foot problems. Journal of Vascular Surgery, 22(4), 485-492.
Boyko, E. J., Ahroni, J. H., Stensel, V., Forsberg, R. C., Davignon, D. R., & Smith, D. G. (1999). A prospective study of risk factors for diabetic
foot ulcers: The Seattle diabetic foot study. Diabetes Care, 22(7), 1036-1042.
Frykberg, R. G., Armstrong, D. G., Giurini, J., Edwards, A., Kravette, M., Kravitz, S. et al. (2000). Diabetic foot disorders:
A clinical practice guideline. American College of Foot and Ankle Surgeons [Electronic version].
Available: http://www.acfas.org/diabeticcpg.html
Goldman, R. J. & Salcido, R. (2002). More than one way to measure a wound: An overview of tools and techniques.
Advances in Skin and Wound Care, 15(5), 236-245.
Kalani, M., Brismar, K., Fagrell, B., Ostergren, J., & Jorneskog, G. (1999). Transcutaneous oxygen tension and toe blood
pressure as predictors for outcome of diabetic foot ulcers. Diabetes Care, 22(1), 147-151.
Kravitz, S. R., McGuire, J., & Shanahan, S. D. (2003). Physical assessment of the diabetic foot. Advances in Skin and Wound
Care, 16(2), 68-75.
Lehto, S., Ronnemaa, T., Pyorala, K., & Laakso, M. (1996). Risk factors predicting lower extremity amputations in patients
with NIDDM. Diabetes Care, 19(6), 607-612.
Mayfield, J. A., Reiber, G. E., Sanders, L. J., Janisse, D., & Pogach, L. M. (1998). Preventive foot care in people with diabetes.
Diabetes Care, 21(12), 2161-2177.
McNeely, M. J., Boyko, E. J., Ahroni, J. H., Stensel, V. L., Reiber, G. E., Smith, D. G. et al. (1995). The independent contributions
of diabetic neuropathy and vasculopathy in foot ulceration: How great are the risks? Diabetes Care, 18(2), 216-219.
Pecoraro, R. E., Ahroni, J. H., Boyko, E. J., & Stensel, V. L. (1991). Chronology and determinants of tissue repair in diabetic
lower-extremity ulcers. Diabetes, 40 1305-1313.
Reiber, G. E., Pecoraro, R. E., & Koepsell, T. D. (1992). Risk factors for amputation in patients with diabetes mellitus: A casecontrol study. Annals of Internal Medicine, 117(2), 97-105.
Royal Melbourne Hospital (2002). Evidence based guidelines for the inpatient management of acute diabetes related foot
complications. Melbourne Health [Electronic version]. Available:
http://www.mh.org.au/ClinicalEpidemiology/new_files/Foot%20guideline%20supporting.pdf
Sales, C., Goldsmith, J., & Veith, F. J. (1994). Handbook of Vascular Surgery. St. Louis, MO: Quality Medical Publishing.
87
Wound cultures
Cultures of the wound should be obtained to guide antibiotic therapy effectively and accurately.
Bacterial swabs can provide information on the predominant flora within a non-progressing,
deteriorating or heavily exudating wound. See Appendix I for swab techniques. Blood cultures are
useful if sepsis is suspected (Perry, Pearson & Miller, 1991). Bacterial swabs or wound cultures do not
diagnose infection but they can be used as guidance for antimicrobial therapy. The diagnosis of
infection is based on clinical symptoms and signs.
C-reactive protein
The sensitivity and specificity of serological markers of infection, e.g., C-reactive protein, tends to
increase with more severe infection (Royal Melbourne Hospital, 2002).
White Blood Cell Count (WBC) and Erythrocyte Sedimentation Rate (ESR)
Elevated lab values should alert the clinician to the possibility of sepsis; however, normal values
should not be used to rule out infection (Armstrong et al., 1996). These lab tests are helpful but must be
considered in conjunction with the clinical assessments of infection.
Imaging
Imaging presentation will vary and should only be conducted to establish or confirm a suspected diagnosis
and/or direct patient management. Accessability and interpretation may be limited to certain areas of specialty:
X-Ray
Plain X-rays are a useful primary imaging tool as they may reveal changes consistent with
osteomyelitis, the presence of foreign bodies, tissue gas or bony abnormalities (Bonham, 2001). Bone
destruction and periosteal changes are not usually evident for 10-21 days following infection (Royal
Melbourne Hospital, 2002).
88
CT scan
CT scans may be indicated in the assessment of suspected bone and joint pathology not evident on
plain radiographs (Frykberg et al., 2000; Lipsky, 1997).
References:
Armstrong, D. G., Lavery, L. A., Sariaya, M. & Ashry, H. (1996). Leukocytosis is a poor indicator of acute osteomyelitis of the foot in
diabetes mellitus. The Journal of Foot and Ankle Surgery, 35(4), 280-283.
Bonham, P. (2001). A critical review of the literature: part I: diagnosing osteomyelitis in patients with diabetes and foot ulcers.
Journal of Wound, Ostomy and Continence Nurses Society, 28(2), 73-88.
Edelson, G. W., Armstrong, D. G., Lavery, L. A. & Caicco, G. (1996). The acutely infected diabetic foot is not adequately
evaluated in an inpatient setting. Journal of the American Podiatric Medical Association, 87(6), 260-265.
Frykberg, R. G., Armstrong, D. G., Giurini, J., Edwards, A., Kravette, M., Kravitz, S. et al. (2000). Diabetic foot disorders:
A clinical practice guideline. American College of Foot and Ankle Surgeons [Electronic version]. Available:
http://www.acfas.org/diabeticcpg.html
Johnson, J. E., Kennedy, E. J., Shereff, M. J., Patel, N. C. & Collier, B. D. (1996). Prospective study of bone, indium-111-labeled white
blood cell, and gallium-67 scanning for the evaluation of osteomyelitis in the diabetic foot. Foot and Ankle International, 17(1),
10-16.
Keenan, A. M., Tindel, N. L. & Alavi, A. (1989). Diagnosis of pedal osteomyelitis in diabetic patients using current scintigraphic
techniques. Archives of Internal Medicine, 149(10), 2262-2266.
Lipsky, B. A. (1997). Osteomyelitis of the foot in diabetic patients. Clinical Infectious Diseases, 25(6), 1318-1326.
Longmaid III, H. E. & Kruskal, J. B. (1995). Imaging infections in diabetic patients. Infectious Disease Clinics of North America,
9(1), 163-182.
Perry, C. R., Pearson, R. L. & Miller, G. A. (1991). Accuracy of cultures of material from swabbing of the superficial aspect of the
wound and needle biopsy in the perioperative assessment of osteomyelitis. Journal of Bone and Joint Surgery, 73(5), 745-749.
Royal Melbourne Hospital (2002). Evidence based guidelines for the inpatient management of acute diabetes related foot
complications. Melbourne Health [Electronic version]. Available:
http://www.mh.org.au/ClinicalEpidemiology/new_files/Foot%20guideline%20supporting.pdf
89
Rx
(1+ to 4+)
Semi-quantitative result
(terms will vary
with each lab)
Suggested
Antibiotic Treatment
No growth
No growth
No growth
No growth
No growth
I
I, II
I, II, III
No growth
Scant or light
Small to moderate
Moderate to heavy
Bacteria observed
I, II, III, IV
Large or heavy
None
None
None
Treat if localized signs
of infection present
Treat considered
infected
Quantitative Growth
(Colony Forming Units/
Gm)
Sector
Prepared by and reprinted with permission of Connie Harris, RN, ET, IIWCC 2000.
References:
Dow, G., Browne, A. & Sibbald, R. G. (1999). Infection in chronic wounds: Controversies in diagnosis and treatment.
Ostomy/Wound Management, 45(8), 23-27, 29-40.
Herruzo-Cabrera, R., Vizcaino-Alcaide, M. J., Pinedo-Castillo, C. & Rey-Calero, J. (1992). Diagnosis of local infection of a burn by
semiquantitative culture of the eschar surface. Journal of Burn Care and Rehabilitation, 13(6), 639-641.
Stotts, N. (1995). Determination of bacterial bioburden in wounds. Advances in Wound Care, 8(4), 28-46.
90
Appendix J:
Use of the Semmes-Weinstein Monofilament
Directions for use of Semmes- Weinstein Monofilament
1. Assess integrity of monofilament (no bends/breaks).
2. Show the monofilament to the patient. Place the end of the monofilament on his/her hand or arm to
show that the testing procedure will not hurt.
3. Ask the patient to turn his/her head and close his/her eyes or look at the ceiling.
4. Hold the monofilament perpendicular to the skin.
Bend
Monofilament
Release
Skin
5. Place the end of the monofilament on the sole of the foot. Ask the patient to say yes when he/she feels
you touching his/her foot with the monofilament. DO NOT ASK THE PATIENT did you feel that? If the
patient does not say yes when you touch a given testing site, continue on to another site. When you
have completed the sequence RETEST the area(s) where the patient did not feel monofilament.
6. Push the monofilament until it bends, then hold for 1-3 seconds.
7. Lift the monofilament from the skin. Do not brush or slide along the skin.
8. Repeat the sequence randomly at each testing site on the foot (see pictures below).
Right Foot
Left Foot
Notes
Apply only to intact skin. Avoid calluses, ulcerated or scarred areas. DO NOT use a rapid or tapping movement.
If the monofilament accidentally slides along the skin, retest that area later in the testing sequence.
Store the monofilament according to the manufacturers instructions.
Clean the monofilament according to agency infection control protocols.
Reference: Registered Nurses Association of Ontario (2004). Reducing Foot Complications for People with Diabetes. Toronto,
Canada: Registered Nurses Association of Ontario.
91
Socks
Adapted from: Zangaro, G. A. & Hull, M. M. (1999). Diabetic neuropathy: Pathophysiology and prevention of foot ulcers.
Clinical Nurse Specialist, 13(2) 57-65
92
Age
Anemia
Anti-inflammatory drugs
Auto-immune disorders
Blood supply
Cytotoxic drugs
Fever
Hypotension
Jaundice
Malignant disease
Malnutrition
Obesity
Renal Failure
Systemic infection
Trauma
Smoking
Vasculopathy
Vitamin deficiency
Zinc deficiency
Local Factors
Affecting Wound Healing
Blood supply
Denervation
Edema
Hematoma
Iatrogenic causes
psychosocial/cognitive
impairment
poor surgical
use of cytotoxic agents
Local infection
Mechanical stress
Radiation
Suture material
Type of tissue
Extrinsic Factors
Affecting Wound Healing
Cultural beliefs
Footwear
shoes
orthotics
Offloading devices
93
Spectrum
SA
Cadexomer Iodine
MRSA Strep
Comments
PS
Anaerobic
VRE
Broad spectrum.
Effective for fungi & virus.
Widely available.
Sheet requires wound contact.
Caution if on thyroid medication.
Ionized Silver
Broad Spectrum.
Effective for fungi & virus.
Sheet requires wound contact.
Silver Sulphadiazine
Polymyxin B Sulphate
Bacitracin Zinc
Selective Use
Metronidazole
gel/cream
Benzyl/ Peroxide
Acetic Acid
Mupuricin
Bactroban
Povidone iodine
Chlorhexidine
Caution
Gentamycin
Fucidic Acid
Polymixin B Sulphate
Bacitracin Zinc
Neomycin
Potent Sensitizer.
Not
Alcohol
Cytotoxic.
Recommended
Hydrogen peroxide
No antimicrobial properties.
Hypochlorite solution
Cytotoxic.
(Dakens)
Legend: (SA = Staphylococcus Aureus), (MRSA = Methicillin Resistant Staph Aureus), (Strep = Streptococci),
(PS = Pseudomona), (F = Fungi Mucor, Aspergillus, Candida Albicans, Candida Tropicalis,
Candida Glabrata, & Saccharomyces), (VRE = Vancomycin-Resistant Enterococci)
Reprinted with permission from Dr. R. Gary Sibbald.
94
95
AHCPR (1994)
Dermagran cleanser
Restore
Other
CLEANSERS
Normal Saline
Shur-Clens
Physiologic.
Indications
Description
Examples
Caution Wound cleansers are for wounds. Skin cleansers are for
intact skin only.
Considerations
There is limited evidence that any specific dressing type enhances the speed of healing of diabetic foot ulcers. It is clear, however, that a moist wound
environment results in more rapid wound healing. Many factors need to be considered when selecting a dressing and these factors may change over
time, necessitating a change in dressing type. Influencing factors include wound type, wound depth, presence and volume of exudates, presence of
infection, surrounding skin condition, likelihood of re-injury and cost. Dressings should never be commenced in isolation and should be a part of the
treatment package of debridement, dressings, pressure offloading and when clinically indicated, antibiotics. This list is not exhaustive. These are
common products used in Ontario. Please check with local suppliers to see what specific dressings are used in your region.
96
IMPREGNATED/
TULLE
Adaptic
Bactigras
Fucidin
Jelonet
Sofratulle
NON-IMPREGNATED
Alldress
ETE
Melolite
Mepitel
Primapore
Release
Tegapore
Telfa
Others
Indications
Description
TRANSPARENT
Examples
ADHESIVE DRESSINGS
TRANSPARENT ADHESIVE
DRESSINGS
Bioclusive
MeFilm
Opsite FlexiFix
Opsite
Tegaderm
Considerations
97
Comes in thick and thin versions.
HYDROCOLLOIDS
Comfeel
Comfeel Plus
Cutinova Hydro
DuoDERM CGF
RepliCare
Restore
SignaDress
Tegasorb
Triad
Others
Indications
Description
Examples
Considerations
Non-adherent.
Non-toxic.
Moisture donating.
Granulating wounds.
HYDROGELS
Curagel
DuoDERM Gel
Intrasite Gel
Normgel
Nu-Gel
Puriclens
Restore Gel
Tegagel
WounDres
Others
Indications
Description
Examples
98
Gel can be applied to gauze ribbon packing to fill deep areas and
promote autolytic debridement .
Considerations
99
Tegagen offers a choice of
a high gelling or a high integrity
product. Review product
monograph and wound needs.
Non-adhesive.
Hemostatic capabilities.
ALGINATES
Algisite
Calcicare
Curasorb
Fibracol
Kaltostat
Melgisorb
Seasorb
Tegagen
Indications
Description
Examples
Considerations
100
Curasalt
Mesalt
Hypergel
HYPERTONIC
SALINE DRESSING
Product absorbs drainage,
becoming an isotonic normal
saline dressing.
Apply dry.
Converts to a solid gel when
activated by moisture.
Promotes comfort.
Decreases dressing bulk.
Debridement of slough.
Infected wounds.
Concentrates drainage.
Considerations
Supports debridement of
exudating wounds.
HYDROFIBRE
Aquacel
Indications
Description
Examples
101
Considerations
Various thickness.
FOAMS
Allevyn
Cutinova
Hydrasorb
Lyofoam Extra
Mepilex
Polymem
3M Foam
Tielle
Biotain
Indications
Description
Examples
102
CombiDERM
CombiDERM ACD
Tielle
Exudry
Versiva
COMPOSITES
Iodosorb
Iodine Agents:
Improves integrity of
macerated skin.
Aesthetic cover.
Acticoat
Aquacel AG
Contreet
Actisorb
See Appendix M
Antimicrobial
Silver Agents:
Considerations
Indications
Description
Examples
103
Available as moistened wipes,
applicators or spray.
Durability varies.
Considerations
Reprinted with permission and revised by Barton and Parslow, 2001 from Caring for Oncology Wounds, Management Guidelines, 1998, ConvaTec Canada
Coloplast
ConvaCare
No Sting
Skin Gel
Skin Prep
Sween
Others
LIQUID BARRIERS
Skin Barriers
CHARCOAL
Actisorb Plus
CarboFLEX
Carbonet Odour
Absorbent Dressing
Indications
Description
Examples
Offloading Device
Advantages
A well-molded minimally
padded cast that maintains
contact with the entire aspect
of the foot and lower leg
Scotchcast Boot
Removable walker
A commercially available
removable boot that reduces
plantar pressures
Halfshoes
Healing Sandals
Mabal Shoe
Felted Foam
Disadvantages
Inexpensive
Easy to apply
Removable (inspection)
Better contact with foot than healing sandal
Comparative rates of healing with TCC
Inexpensive
Accessible
Therapeutic Footwear
Depth inlay shoes
104
References:
Armstrong, D. G. & Lavery, L. A. (1998a). Evidence-based options for offloading diabetic wounds. Clinics in Podiatric Medicine
and Surgery, 15(1), 95-105.
Armstrong, D. G, Lavery, L. A., Kimbriel, H. R., Nixon, B. P., & Boulton, A. J. M. (2003). Activity patterns of patients with diabetic
foot ulceration: Patients with active ulceration may not adhere to a standard pressure offloading regimen. Diabetes Care, 26(9),
2595-2597.
Armstrong, D. G., Nguyen, H. C., Lavery, L. A., Van Schie, C. H. M., Boulton, A. J. M., & Harkless, L. B. (2001). Offloading the
diabetic foot wound: A randomized clinical trial. Diabetes Care, 24(6), 1019-1022.
Armstrong, D. G., van Schie, C. H. M., & Boulton, A. J. M. (2001). Offloading foot wounds in people with diabetes.
In D. L. Krasner, G. T. Rodehaver, & R. G. Sibbald (Eds.), Chronic wound care: A clinical resource book for healthcare professionals.
(3rd ed.). (pp. 599-615). Wayne, PA: HMP Communications.
Birke, J. A., Pavich, M. A., Patout Jr., C. A., & Horswell, R. (2002). Comparison of forefoot ulcer healing using alternative
offloading methods in patients with diabetes mellitus. Advances in Skin & Wound Care, 15(5), 210-215.
Fleischli, J. G., Lavery, L. A., Vela, S. A., Ashry, H., & Lavery, D. C. (1997). Comparison of strategies for reducing pressure at the
site of neuropathic ulcers. Journal of the American Podiatric Medical Association, 87(10), 466-472.
Inlow, S., Kalla, T. P., & Rahman, J. (1999). Downloading plantar foot pressures in the diabetic patient. Ostomy/Wound
Management, 45(10), 28-38.
Knowles, E. A., Armstrong, D. G., Hayat, S. A., Khawaja, K. I., Malik, R. A., & Boulton, A. J. M. (2002) Offloading diabetic foot
wounds using the scotchcast boot: A retrospective study. Ostomy/Wound Management, 48(9), 50-53.
Zimny, S., Schatz, H., & Pfoh, U. (2003). The effects of applied felted foam on wound healing and healing times in the therapy
of neuropathic diabetic foot ulcers. Diabetes Medicine, 20 622-625.
105
Appendix P:
Resources for Diabetic Foot Ulcer Information
The following websites provide information on diabetic foot ulcers. These are examples only and are not
intended to be a comprehensive listing.
Organizations
Corporations
Carrington www.carringtonlabs.com
Coloplast www.us.coloplast.com
Convatec www.convatec.com/en-ca
Hollister www.hollister.com
ICN www.icncanada.com
Kendall www.kendallhq.com
3M www.mmm.com or www.3m.com
Molnlycke www.molnlycke.com
106
Orthotic fabrication
custom-made, adjustments, braces, aircast or TCC
Shoe modification
rocker sole, sole widening
Assistive devices
canes and walkers, hosiery, heel protectors
Service Providers
Pedorthists
Canada: www.pedorthic.ca
U.S: www.pedorthics.org
Orthotists
Canada: www.pando.ca
U.S.: www.oandp.org
Chiropodists/Podiatrists
Ontario: www.cocoo.on.ca
Canada: www.podiatrycanada.org
Occupational Therapists
Canada: www.caot.ca
U.S.: www.aota.org
107
Implementing guidelines in practice that result in successful practice changes and positive clinical impact
is a complex undertaking. The Toolkit is one key resource for managing this process.
The Toolkit is available through the Registered Nurses Association of Ontario. The document is
available in a bound format for a nominal fee, and is also available free of charge from the RNAO
website. For more information, an order form or to download the Toolkit, please visit the RNAO
website at www.rnao.org/bestpractices.
108
Notes:
109
Notes:
110
Notes:
111
Notes:
112
March 2005
0-920166-68-7