• Wound, Ostomy, and Continence Nurses Society (WOCN). Guideline for management of wounds in patients with lower-extremity neuropathic disease. Glenview (IL): Wound, Ostomy, and Continence Nurses Society (WOCN); 2004. 57 p. (WOCN clinical practice guideline; no. 3). [85 references]

This is the current release of the guideline.

Wounds due to lower-extremity neuropathic disease (LEND)

Diagnosis
Evaluation
Management
Prevention
Screening
Treatment

Dermatology
Family Practice
Internal Medicine
Nursing
Physical Medicine and Rehabilitation
Podiatry

Advanced Practice Nurses
Allied Health Personnel
Health Care Providers
Nurses
Physical Therapists
Physician Assistants
Physicians

• To present an evidence-based guideline for the management of wounds in patients with lower-extremity neuropathic disease (LEND)
• To provide consistent, research-based, clinical information with the goal of improved, cost-effective patient outcomes as well as increased wound research in the areas where there are gaps between research and practice

Patients with lower-extremity neuropathic disease (LEND) with wounds

Evaluation

1. Assessment of causative and contributive factors and significant signs and symptoms to differentiate types of lower-extremity ulcers
2. Review of health history (risk factors for lower extremity neuropathic disease [LEND], wound history, pain history, pharmacologic history of prescribed and self-prescribed medications)
3. Review of pertinent labs (hemoglobin A-1 C [HbA1c], serum B-12, thyroid stimulating hormone [TSH], and T4) to identify risk markers for LEND
4. Foot and lower-extremity examination (dermatologic status, localized inflammation, edema, perfusion status, musculoskeletal/biomechanical status, foot care routine, footwear assessment, wound characteristics, complications)

Prevention

1. Identification of high-risk patients and referral to foot care specialist
2. Neuropathic foot screen
3. Amputation prevention program including annual foot screening, patient education, appropriate footwear selection, daily self-inspection, and management of simple foot problems
4. Professional assistance in fitting shoes

Treatment

1. Offloading with wound closure, walking splints, wedge sole shoes, healing shoes with large toe box
2. Wound management
3. Debridement
4. Dressings, including use of:
   • Growth factors (rh PDGF-BB)
   • Biological wound coverings
5. Referral for assessment of vascular perfusion and need for surgical intervention in cases of infection
6. Systemic antibiotics for infection
7. Nutritional management including a multivitamin preparation, when applicable
   • L-Arginine supplementation
8. Referral for pain management and consideration of electrical stimulation, Gabapentin, and Capsaicin Cream
9. Regular exercise program
10. Management of edema
    • Monitor patients and referral for further evaluation as needed
11. Adjunctive therapies (e.g., hyperbaric oxygen therapy), modifiable risk factors management, patient instruction in chronic disease management

• Risk for and incidence of lower extremity neuropathic disease (LEND) with foot ulcers
• Signs and symptoms of LEND
• Sensitivity and specificity of diagnostic tests
• Wound healing
• Complications of LEND

Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

The primary authors of this guideline independently conducted a literature search of Medline and Cochrane Library databases to identify studies and systematic reviews published in English from 1980 through 2003. The following Medical Subject Headings (MeSH) were used to search for each specific question related to lower-extremity neuropathic disease (LEND)-lower-extremity wounds, peripheral neuropathy, neuropathic disease, neuropathic wounds, and diabetic neuropathy. The search targeted meta-analyses, randomized controlled trials (RCTs), prospective clinical trials, retrospective studies, and systematic reviews. Bibliographies of selected articles also were reviewed.

A total of 174 articles were identified and reviewed for this guideline.

Weighting According to a Rating Scheme (Scheme Given)

Primary reviewers read and summarized the articles. Each article was assigned a level of evidence rating as follows:

Level I: A randomized controlled trial (RCT) that demonstrates a statistically significant difference in at least one important outcome defined by p < .05.

Level II: A RCT that does not meet Level I criteria.

Level III: A nonrandomized trial with contemporaneous controls selected by some systematic method. A control may have been selected because of its perceived suitability as a treatment option for individual patients.

Level IV: A before-and-after study or a case series of at least 10 patients using historical controls or controls drawn from other studies.

Level V: A case series of at least 10 patients with no controls.

Level VI: A case report of fewer than 10 patients.

Systematic Review

Not stated

Expert Consensus

Not stated

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Peer Review

Not stated

A level of evidence rating (A-C) has been assigned to specific recommendations and is defined at the end of the "Major Recommendations" field. Citations in support of individual recommendations are identified in the original guideline document.

Assessment

1. Prior to treatment, assess causative and contributive factors and significant signs and symptoms to differentiate types of lower-extremity ulcers, which require varying treatment modalities.
2. Review health history to address risk factors for lower-extremity neuropathic disease (LEND), wound history, pain history, and pharmacologic history of prescribed and self-prescribed medications. Level of evidence = C
3. Review pertinent labs to identify risk markers for LEND. Level of evidence = C
   1. Elevated hemoglobin A1 C (HbA1c) levels.
   2. Serum B-12 (Cyanocobalamin) deficiency.
   3. Untreated elevated thyroid stimulating hormone (TSH), T4 levels.
4. Conduct foot and lower-extremity examination. Level of evidence = C
   1. Assess dermatologic status for callus development.
   2. Determine localized inflammation by palpation and dermal thermometry.
   3. Determine if edema is dependent or pitting, localized or generalized, or bilateral or unilateral.
   4. Assess perfusion status by assessing skin temperature, capillary refill, venous refill, color changes, and paresthesias.
   5. Assess musculoskeletal/biomechanical status for foot deformities, muscle weakness, or gait abnormalities.
   6. Assess neurological status for loss of protective sensation and diminished tendon reflexes.
   7. Assess patient's foot care routine for daily skin cleansing and moisturizing, surveillance for foot problems, and barefoot or stocking foot walking.
   8. Assess patient's footwear for proper sizing and design and use and status of insoles.
   9. Determine wound characteristics including location, pain, shape, and size of the wound, wound base, wound edges, periwound skin, exudates, and presence of necrosis.
   10. Assess for complications, such as cellulitis, gangrene, osteomyelitis, or Charcot fracture (neuropathic osteoarthropathy).

5. Perform a comprehensive foot examination annually on patients with diabetes to identify risk factors predictive of ulcers and amputations. Health-care providers should perform a visual inspection of patient's feet at each routine visit.

Prevention

1. A multidisciplinary approach is recommended for persons with diabetes, insensate feet, and peripheral neuropathy. Level of evidence = C
2. Identify individuals at risk for foot ulceration, considering loss of protective sensation, history of previous ulceration or amputation, elevated plantar pressure, rigid foot deformity, poor diabetes control (HgA1c >7%), duration of diabetes greater than 10 years
3. Refer high-risk patients to foot care specialists for ongoing preventive care and lifelong surveillance. Level of evidence = C
4. Perform neuropathic foot screen to identify current foot problems and initiate a prescription for appropriate prevention measures and treatment, based on risk category.
5. Initiate a lower-extremity amputation prevention program, that includes
   1. Annual foot screening
   2. Patient education
   3. Appropriate footwear selection
   4. Daily self-inspection of the foot by the patient
   5. Management of simple foot problems
6. Encourage professional assistance in fitting shoes properly because peripheral neuropathy may preclude patients from recognizing proper fit.

Treatment

1. Recommend that patients with wounds and LEND seek care guided by a clinical wound expert.
2. Utilize a multidisciplinary team for persons with foot ulcers. Level of evidence = B
3. Relate wound treatments to adequacy of perfusion status.

Offloading

4. Ensure adequate offloading of pressure through wound closure.
5. Utilize assistive devices (e.g., walking splints, wedge sole shoes, healing shoes with large toe box) to provide support, balance, and offloading of the affected site.

Wound Management

6. Maintain dry stable eschar on noninfected, ischemic, neuropathic wounds. Level of evidence = C
7. Cleanse wound with noncytotoxic cleansers.

Debridement

8. Recommend debridement of neuropathic wounds and calluses, as needed, throughout the healing process. Level of evidence = C
9. Debride ulcers with extensive cellulitis and/or osteomyelitis and refer for pharmacological (intravenous) intervention. Level of evidence = C

Dressings

10. Choose dressings that promote a moist wound environment. Level of evidence = B
11. Reevaluate the wound dressings on a periodic basis throughout the treatment process. Level of evidence = C
12. Consider the use of growth factors (rh PDGF-BB) for foot ulcers after necrotic tissue has been debrided, infection is cleared, and adequate perfusion has been established. Level of evidence = A
13. Consider the use of biological wound coverings for the treatment of noninfected diabetic foot ulcers. Level of evidence = B

Infection

14. Observe clinical manifestations of infection, which may be subtle due to reduced blood flow or absence of sensation in the neuropathic foot.
15. Infected neuropathic wounds may be limb threatening and require immediate referral for assessment of vascular perfusion and need for surgical intervention. Level of evidence = C

Antimicrobials

16. Tissue biopsy is considered the gold standard to confirm diagnosis of infection. Quantitative swab cultures have been demonstrated to be a reasonable alternative in clinical practice. Level of evidence = B
17. Systemic antibiotics are warranted in the management of ulcers when bacteremia, sepsis, advancing cellulitis, or osteomyelitis occurs, and caution must be exercised against multiple-antibiotic-resistant organisms. Level of evidence = C

Osteomyelitis

18. As a noninvasive technology, magnetic resonance imaging (MRI) has demonstrated the highest sensitivity and specificity for diagnosing osteomyelitis in patients with diabetes and foot ulcers.
19. Refer the patient for further evaluation for suspected infection, positive probe to bone, and radiographic changes demonstrating Charcot osteoarthropathy. Level of evidence = C

Nutrition

20. Utilize basic principles of nutritional management of the patient with diabetes mellitus to control serum glucose, hyperlipidemia, and hypertension for the patient with neuropathic foot ulcers. Level of evidence = C
21. Select populations, such as elderly individuals and people on calorie-restricted diets, may benefit from a multivitamin preparation. Level of evidence = C
22. Consider L-Arginine supplementation.

Pain Management

23. Refer to resources for pain management.
24. Consider referral for a course of electrical stimulation to relieve chronic diabetic neuropathic pain in patients who do not respond to conventional treatment. Level of evidence = C
25. Consider Gabapentin for relief of neuropathic pain described as burning, tingling, or allodynia symptoms.
26. Utilize Capsaicin Cream (0.25% & 0.075%) applied thinly three times a day (tid) to four times a day (qid) to affected areas.

Exercise

27. Institute a regular exercise program, adapted to the presence of complications.
28. Exercise must be conducted with caution due to the insensate lower extremities.

Management of Edema

29. Monitor patients with neuropathy, as they may have no sensation of pain related to the compression bandage.
30. Refer for further evaluation for cellulitis, osteomyelitis, atypical ulcers, and new onset or diagnosis Charcot foot.

Adjunctive Therapies

31. Consider hyperbaric oxygen therapy (HBOT) for Wagner grades III and IV ulcers.
32. Manage modifiable risk factors, including smoking, weight, and alcohol intake.
33. Instruct patients in chronic disease management (e.g., diabetes, human immunodeficiency virus [HIV], and their effects on lower-extremity peripheral neuropathy)

Definitions

Levels-of-Evidence Rating

Level A: Two or more supporting RCTs of LEND in humans (at Levels I or II), meta-analysis of RCTs, or Cochrane Systematic Review of RCTs

Level B: One or more supporting controlled trials of LEND in humans or two or more trials in an animal model (at Level III)

Level C: One supporting controlled trial, at least two supporting case series that were descriptive studies in humans, or expert opinion

A clinical algorithm is provided in the original guideline to determine wound etiology.

The type of evidence is identified for selected recommendations (see "Major Recommendations" field) and defined as follows:

Level A: Two or more supporting randomized controlled tirals (RCTs) of lower extremity neuropathic disease in humans (at Levels I or II), meta-analysis of RCTs, or Cochrane Systematic Review of RCTs

Level B: One or more supporting controlled trials of lower extremity neuropathic disease in humans or two or more trials in an animal model (at Level III)

Level C: One supporting controlled trial, at least two supporting case series that were descriptive studies in humans, or expert opinion

• Identification of patients with peripheral neuropathy who are at risk for developing wounds
• Identification of patients whose current wounds are caused or complicated by peripheral neuropathy
• Implementation of appropriate strategies and plans to:
  • Attain/maintain intact skin
  • Manage pain and sensory issues
  • Identify/manage complications promptly
  • Optimize potential for wound healing
  • Promote limb preservation
  • Involve patient and caregiver in self-management

• Wounds treated with topical antimicrobials may develop resistant organisms over time.
• Topical creams, ointments, and gels containing antimicrobials may also cause sensitivity reactions.

An implementation strategy was not provided.

Getting Better
Living with Illness
Staying Healthy

Effectiveness
Patient-centeredness

• Wound, Ostomy, and Continence Nurses Society (WOCN). Guideline for management of wounds in patients with lower-extremity neuropathic disease. Glenview (IL): Wound, Ostomy, and Continence Nurses Society (WOCN); 2004. 57 p. (WOCN clinical practice guideline; no. 3). [85 references]

Not applicable: The guideline was not adapted from another source.

2004

Wound, Ostomy, and Continence Nurses Society - Professional Association

Wound, Ostomy, and Continence Nurses Society

Wound, Ostomy, and Continence Nurses (WOCN) Lower-Extremity Neuropathic Disease Panel

Wound Guidelines Task Force

Wound, Ostomy, and Continence Nurses (WOCN) Lower-Extremity Neuropathic Disease Panel

Primary Authors: Penny Ellen Crawford, MSN, BC, FNP, CWOCN, Atlantic Shores Wellness Center, Virginia Beach, VA; Myra Fields-Varnado, BS, RN, CDE, CWOCN, LSU Health Sciences Center, Independence, LA

Clinical Practice Committee Chair: Judy A. Dutcher, MS, APRN-BC, CWOCN, Connecticut Support Services, Plainville, CT

WOCN Society President: Laurie McNichol, MSN, RN, GNP, CWOCN, Advanced Home Care, High Point, NC

Wound Guidelines Task Force

Chair: Catherine R. Ratliff, PhD, APRN-BC, CWOCN, CS, University of Virginia Health System, Charlottesville, VA

Members: Phyllis A. Bonham, MSN, RN, CWOCN, Special Care, Mt. Pleasant, SC; Diane E. Bryant, MSN, RN, CWOCN, Brigham and Women's Hospital, Boston, MA; Bonny Flemister, MSN, RN, CWOCN, CS, ANP, GNP, The Diagnostic Clinic of Longview, Longview, TX; Margaret Goldberg, MSN, RN, CWOCN, Wound Treatment Center, Delray Medical Center, Delray Beach, FL; Jan J. Johnson, MSN, RN, CWOCN, ANP, Duke University Medical Center, Durham, NC; Carol Paustian, BSN, RN, CWOCN, Medline Industries, Omaha, NE

Scribe: Ronald Palmer, Fullerton, CA

Individuals involved in developing clinical practice guidelines are charged by the Wound Ostomy and Continence (WOCN) Society with the task of developing objective, complete, and practical guidelines. Financial relationships with commercial companies could conflict with that task when a company's products or services are related to the subject of the guideline. To ensure the integrity of WOCN Society and the WOCN Clinical Practice Guidelines, all participants in the development of clinical practice guidelines submitted a Conflict of Interest Disclosure Form to WOCN prior to participation in guideline activity. The WOCN Executive Director reviewed the forms and determined that no conflict of interest existed with any individual panel member. In addition, panel members disclosed any financial relationships with commercial companies during panel meetings.

Members of the WOCN Society Council, the WOCN Ad hoc Ethics Committee, and the Journal of Wound, Ostomy Continence Nurses Society Editor receive no compensation from companies that provide products or services related to the practice of WOC (ET) nursing or from firms that provide services to WOCN Society.

This is the current release of the guideline.

None available

None available

This NGC summary was completed by ECRI on November 9, 2004. The information was verified by the guideline developer on November 30, 2004.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Per the guideline developer, the Wound, Ostomy and Continence Nurses (WOCN) Society retains the copyright to the material in the Management of wounds in patients with lower-extremity neuropathic disease. Any reproduction without consent is prohibited. Written requests to reproduce any portion of the material contained within this guideline may be directed to Catherine Underwood, Executive Director, Wound, Ostomy and Continence Nurses Society national office: 4700 W. Lake Avenue, Glenview, IL 60025-1485.