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## Complete Summary

#### GUIDELINE TITLE

Chronic wounds of the lower extremity.

#### BIBLIOGRAPHIC SOURCE(S)

American Society of Plastic Surgeons. Evidence-based clinical practice
guideline: chronic wounds of the lower extremity. Arlington Heights
(IL): American Society of Plastic Surgeons; 2007 May. 21 p. \[132
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse (NGC)**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [July 08, 2008, Fluoroquinolones (ciprofloxacin, norfloxacin,
    ofloxacin, levofloxacin, moxifloxacin,
    gemifloxacin)](http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone):
    A BOXED WARNING and Medication Guide are to be added to the
    prescribing information to strengthen existing warnings about the
    increased risk of developing tendinitis and tendon rupture in
    patients taking fluoroquinolones for systemic use.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Chronic wounds of the lower extremity, including vascular (e.g.,
arterial, venous, or mixed ulcers), pressure ulcers, and neuropathic
(e.g., diabetic ulcers)

#### GUIDELINE CATEGORY

Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Dermatology\
Family Practice\
Plastic Surgery\
Surgery

#### INTENDED USERS

Advanced Practice Nurses\
Health Care Providers\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To conduct a systematic review of existing scientific literature
addressing the assessment and treatment of chronic wounds of the lower
extremity and to develop recommendations that fairly reflect current
accepted medical standards

#### TARGET POPULATION

Patients with chronic wounds of the lower extremity

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Assessment**

1.  Medical history and physical exam

2.  Assessment for venous insufficiency, using physical findings,
    Doppler ultrasonography, Duplex scanner plethysmography and
    venography

3.  Assessment for arterial occlusive disease (history and ankle
    brachial index \[ABI\])

4.  Assess for comorbidities of diabetes

5.  Assess history and characteristics of wound, including evaluation
    for infection

6.  Assess for confounding factors, allergies, osteomyelitis, remote or
    systemic infection, and comorbid risk factors

7.  Assess pain, functional status, and quality of life

8.  Regular follow-up

**Treatment/Management**

1.  Debridement

2.  Pressure relief

3.  Infection control

4.  Management of exudate

5.  Management of complications, including osteomyelitis and infection

6.  Measures to prevent recurrence, including patient education,
    therapeutic modalities, and exercise programs

#### MAJOR OUTCOMES CONSIDERED

Not stated

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

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

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

**Literature Search and Admission of Evidence**

This study was carried out using a prospective systematic method for
identifying and evaluating current literature on the treatment of
chronic wounds of the lower extremities. To identify relevant
literature, a comprehensive search of the following databases was
performed: OVID, Medline, CINAHL, Embase, the Cochrane Wounds Group
database within the Cochrane Collaboration Library, the Agency for
Healthcare Research and Quality (AHRQ) Clinical Practice Guidelines, and
the National Guideline Clearinghouse.™ Additionally, the World Wide Web
was searched using meta-search engines for national and international
guidelines. The search term combination captured the concept
\"practice-guidelines AND wound\" using a wide range of indexing terms,
free text words and word variants. Search limits restricted results to
English-language manuscripts.

Articles were selected if they met the following criteria: guideline,
systematic review, consensus statement, care protocol, or healthcare
technology assessment produced by national or international professional
organizations and societies or governmental agencies; subject:
comprehensive management of wounds of the lower extremity. From this
list, key articles were identified and corresponding bibliographies hand
searched for citations and manuscripts relevant to clinical questions
about patient assessment, treatment, follow-up and prevention of wound
recurrence.

Excluded from the search were articles that specifically addressed
assessment and treatment of patients with burn wounds of the lower
extremity, patients whose wounds were surgically closed, and patients
with uncomplicated wounds that heal by primary intention (matrix
deposition, contraction, and epithelialization).

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Evidence Rating Scale for Diagnostic Studies**

  -------------------------------------------------------------------------
  **Level of   **Qualifying Studies**
  Evidence**   
  ------------ ------------------------------------------------------------
  I            High-quality, multi-centered or single-centered, cohort
               study validating a diagnostic test (with \"gold\" standard
               as reference) in a series of consecutive patients; or a
               systematic review of these studies

  II           Exploratory cohort study developing diagnostic criteria
               (with \"gold\" standard as reference) in a series of
               consecutive patients; or a systematic review of these
               studies

  III          Diagnostic study in nonconsecutive patients (without
               consistently applied \"gold\" standard as reference); or a
               systematic review of these studies

  IV           Case-control study; or any of the above diagnostic studies
               in the absence of a universally accepted \"gold\" standard

  V            Expert opinion; case report or clinical example; or evidence
               based on physiology, bench research, or \"first principles\"
  -------------------------------------------------------------------------

**Evidence Rating Scale for Prognostic Studies**

  ------------------------------------------------------------------------
  **Level of   **Qualifying Studies**
  Evidence**   
  ------------ -----------------------------------------------------------
  I            High-quality, multi-centered or single-centered,
               prospective cohort study with adequate power; or a
               systematic review of these studies

  II           Lesser-quality prospective cohort study; retrospective
               study; untreated controls from a randomized controlled
               trial; or a systematic review of these studies

  III          Case-control study; or a systematic review of these studies

  IV           Case series

  V            Expert opinion; case report or clinical example; or
               evidence based on physiology, bench research, or \"first
               principles\"
  ------------------------------------------------------------------------

**Evidence Rating Scale for Therapeutic Studies**

  -----------------------------------------------------------------------
  **Level of   **Qualifying Studies**
  Evidence**   
  ------------ ----------------------------------------------------------
  I            High-quality, multi-centered or single-centered,
               randomized controlled trial with adequate power; or a
               systematic review of these studies

  II           Lesser-quality, randomized controlled trial; prospective
               cohort study; or a systematic review of these studies

  III          Retrospective comparative study; case-control study; or a
               systematic review of these studies

  IV           Case series

  V            Expert opinion; case report or clinical example; or
               evidence based on physiology, bench research, or \"first
               principles\"
  -----------------------------------------------------------------------

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

**Critical Appraisal of the Literature**

Relevant articles were categorized by study type: randomized controlled
trial, systematic review, cohort study, and case-control study. Each
article was critically appraised for study quality according to criteria
referenced in key publications on evidence-based medicine. Depending on
type (prognostic, diagnostic, or therapeutic) and quality of study, each
article was assigned a corresponding level of evidence according to the
American Society of Plastic Surgeons (ASPS) Evidence Rating Scales (see
\"Rating Scheme for the Strength of the Evidence\" above), which were
modified from scales developed by other surgical specialties and
authorities on evidence-based medicine.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

**Development of Clinical Practice Recommendations**

Practice recommendations were developed through critical appraisal of
the literature and consensus of the American Society of Plastic Surgeons
(ASPS) Health Policy Committee. Recommendations are based on the
strength of supporting evidence and were graded according to the ASPS
Grades of Recommendation Scale (see \"Rating Scheme for the Strength of
the Recommendations\" below), which was modified from scales used by
other surgical specialties and authorities in the practice of
evidence-based medicine.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

  -------------------------------------------------------------------------------
  **Grade**   **Descriptor**   **Qualifying     **Implications for Practice**
                               Evidence**       
  ----------- ---------------- ---------------- ---------------------------------
  A           Strong           Level I evidence Clinicians should follow a strong
              Recommendation   or consistent    recommendation unless a clear and
                               findings from    compelling rationale for an
                               multiple studies alternative approach is present.
                               of levels II,    
                               III, or IV       

  B           Recommendation   Levels II, III,  Generally, clinicians should
                               or IV evidence   follow a recommendation but
                               and findings are should remain alert to new
                               generally        information and sensitive to
                               consistent       patient preference.

  C           Option           Levels II, III,  Clinicians should be flexible in
                               or IV evidence,  their decision-making regarding
                               but findings are appropriate practice, although
                               inconsistent     they may set bounds on
                                                alternatives; patient preference
                                                should have a substantial
                                                influencing role.

  D           Option           Level V; little  Clinicians should consider all
                               or no systematic options in their decision-making
                               empirical        and be alert to new published
                               evidence         evidence that clarifies the
                                                balance of benefit versus harm;
                                                patient preference should have a
                                                substantial influencing role.
  -------------------------------------------------------------------------------

#### COST ANALYSIS

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

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Approved by the Executive Committee of the American Society of Plastic
Surgeons, May 2007

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Definitions for the levels of evidence for diagnostic, prognostic, and
therapeutic studies (I--V) and the strength of the recommendations
(A--D) are provided at the end of the \"Major Recommendations\" field.

+----------------------------------+------------------------------+----+
| **Recommendations for Patient    | **Supporting Evidence**      | *  |
| Assessment**                     |                              | *G |
|                                  |                              | ra |
|                                  |                              | de |
|                                  |                              | ** |
+==================================+==============================+====+
| **General**\                     | Expert Opinion               | *  |
| \                                |                              | *D |
| Medical History:                 |                              | ** |
|                                  |                              |    |
| -   Assess comorbidities,        |                              |    |
|     medications, allergies, and  |                              |    |
|     family history               |                              |    |
|                                  |                              |    |
| Physical exam:                   |                              |    |
|                                  |                              |    |
| -   Assess cardiovascular status |                              |    |
|     (pulse, blood pressure)      |                              |    |
|                                  |                              |    |
| -   Perform focused examination  |                              |    |
|     of the legs                  |                              |    |
+----------------------------------+------------------------------+----+
| **Venous Insufficiency**         |                              |    |
+----------------------------------+------------------------------+----+
| Historical findings suggestive   | (Baker et al., 1991; Berard  | *  |
| of venous insufficiency include: | et al., 2002; Blomgren et    | *B |
|                                  | al., 2001; Labropoulos et    | ** |
| -   Prior history of             | al., \"Patterns,\" 2007;     |    |
|     thrombophlebitis, venous     | Fink et al., 2002; Dajani et |    |
|     thromboembolism, and/or deep | al., 1988)                   |    |
|     vein thrombosis              |                              |    |
|                                  |                              |    |
| -   History of symptomatic       |                              |    |
|     varicosities during          |                              |    |
|     pregnancy                    |                              |    |
|                                  |                              |    |
| -   Surgical history of lower    |                              |    |
|     extremity trauma, vascular   |                              |    |
|     injury or previous varicose  |                              |    |
|     vein surgery                 |                              |    |
|                                  |                              |    |
| -   Hypercoagulable states       |                              |    |
|     (e.g., cancer, infection,    |                              |    |
|     Factor VIII excess)          |                              |    |
+----------------------------------+------------------------------+----+
| Physical findings suggestive of  | (Blomgren et al., 2001;      | *  |
| venous insufficiency include:    | Labropoulos et al.,          | *B |
|                                  | \"Patterns,\" 2007; Wong,    | ** |
| -   Edema                        | Duncan, & Nichols, 2003)     |    |
|                                  |                              |    |
| -   Wound presentation as        |                              |    |
|     shallow ulcer in the lower   |                              |    |
|     third of leg                 |                              |    |
|                                  |                              |    |
| -   Venous dermatitis            |                              |    |
|                                  |                              |    |
| -   Lipodermatosclerosis         |                              |    |
|                                  |                              |    |
| -   Varicose veins               |                              |    |
+----------------------------------+------------------------------+----+
| Diagnostic Tests:                | (Shami et al., 1993; Alguire | *  |
|                                  | & Mathes,1997; Wong, Duncan, | *B |
| -   Doppler ultrasonography      | & Nichols, 2003; Baxter &    | ** |
|                                  | Polak, 1993)                 |    |
| -   Duplex scanner               |                              |    |
|     plethysmography and          |                              |    |
|     venography                   |                              |    |
+----------------------------------+------------------------------+----+
| Determine severity of venous     | Expert Opinion               | *  |
| insufficiency                    |                              | *D |
|                                  |                              | ** |
+----------------------------------+------------------------------+----+
| **Arterial Occlusive Disease**   |                              |    |
+----------------------------------+------------------------------+----+
| Assess for a history of arterial | (Wipke-Tevis et al., 2000;   | *  |
| occlusive disease:               | Dormandy & Murray, 1991;     | *B |
|                                  | Jelnes et al., 1986; Criqui  | ** |
| -   Arterial peripheral vascular | et al., 1985; Marston et     |    |
|     disease                      | al., 2006; Hiatt, Hoag, &    |    |
|                                  | Hamman, 1995; Khan et al.,   |    |
| -   Ischemic complaints          | 2006; Wang et al., 2005;     |    |
|                                  | Henke et al., 2005)          |    |
| -   Rest pain                    |                              |    |
+----------------------------------+------------------------------+----+
| Assess for factors suggestive of | (Khan et al., 2006)          | *  |
| arterial compromise:             |                              | *B |
|                                  |                              | ** |
| -   Cold, pale feet (in warm     |                              |    |
|     environment)                 |                              |    |
|                                  |                              |    |
| -   Shiny, taut skin             |                              |    |
|                                  |                              |    |
| -   Dependent rubor              |                              |    |
|                                  |                              |    |
| -   Punched out appearance of    |                              |    |
|     ulcer                        |                              |    |
+----------------------------------+------------------------------+----+
| Diagnostic Tests:                | (Baxter & Polak, 1993;       | *  |
|                                  | Dormandy & Murray, 1991;     | *B |
| -   Ankle brachial index (ABI)   | Jelnes et al., 1986;         | ** |
|                                  | Stoffers et al., 1997;       |    |
| -   If \<0.8, referral to        | Marston et al., 2006; Hiatt, |    |
|     specialist may be necessary  | Hoag, & Hamman, 1995; Khan   |    |
|     to assess for arterial       | et al., 2006; de Vries et    |    |
|     occlusive disease            | al., 2006; Ouwendijk et al., |    |
|                                  | 2005)                        |    |
+----------------------------------+------------------------------+----+
| Determine severity of arterial   | (Marston et al., 2006;       | *  |
| occlusive disease:               | O\'Meara et al., 2000)       | *B |
|                                  |                              | ** |
| -   ABI 0.6 to 0.8, suggestive   |                              |    |
|     of peripheral arterial       |                              |    |
|     occlusive disease            |                              |    |
|                                  |                              |    |
| -   ABI \<0.5, suggestive of     |                              |    |
|     critical ischemia            |                              |    |
|                                  |                              |    |
| -   ABI \>1.2, suggestive of     |                              |    |
|     calcification and            |                              |    |
|     noncompressibility of        |                              |    |
|     arterial wall                |                              |    |
|                                  |                              |    |
| -   Consider vascular            |                              |    |
|     intervention or              |                              |    |
|     reconstruction               |                              |    |
|                                  |                              |    |
| -   Contrast arteriography (or   |                              |    |
|     magnetic resonance           |                              |    |
|     angiography)                 |                              |    |
|                                  |                              |    |
| -   Refer to vascular            |                              |    |
|     specialist, if needed        |                              |    |
+----------------------------------+------------------------------+----+
| **Diabetes**                     | (Marston et al., 2006; Hiatt | *  |
|                                  | et al., 1995; Pham et al.,   | *B |
| -   Assess for comorbidities     | 2000; Abbott et al., 1998;   | ** |
|     (microangiopathy,            | Yasuhara et al., 2002)       |    |
|     neuropathy, impaired immune  |                              |    |
|     response)                    |                              |    |
|                                  |                              |    |
| -   Assess for sensory           |                              |    |
|     derangement (e.g.,           |                              |    |
|     Semmes-Weinstein)            |                              |    |
+----------------------------------+------------------------------+----+
| **History and Characteristics of |                              |    |
| the Wound**                      |                              |    |
+----------------------------------+------------------------------+----+
| Document history of the wound:   | Expert Opinion               | *  |
|                                  |                              | *D |
| -   Date and site(s) current     |                              | ** |
|     ulceration began             |                              |    |
|                                  |                              |    |
| -   Date and site(s) of previous |                              |    |
|     ulcers                       |                              |    |
|                                  |                              |    |
| -   Prior duration to heal       |                              |    |
|                                  |                              |    |
| -   Length of prior disease-free |                              |    |
|     interval(s)                  |                              |    |
|                                  |                              |    |
| -   Prior treatments             |                              |    |
|                                  |                              |    |
| -   Past surgical history of     |                              |    |
|     venous operation             |                              |    |
|                                  |                              |    |
| -   Use of compression garments  |                              |    |
+----------------------------------+------------------------------+----+
| Document characteristics of the  | (Marston et al., 2006;       | *  |
| wound:                           | O\'Meara et al., 2000)       | *B |
|                                  |                              | ** |
| -   Size                         |                              |    |
|                                  |                              |    |
| -   Nature of wound base tissue  |                              |    |
|                                  |                              |    |
| -   Amount of drainage           |                              |    |
+----------------------------------+------------------------------+----+
| Evaluate wound for evidence of   | (Cutting, 1998; Gardner et   | *  |
| infection                        | al., 2001)                   | *B |
|                                  |                              | ** |
| -   Necrotic tissue              |                              |    |
|                                  |                              |    |
| -   Purulent drainage            |                              |    |
|                                  |                              |    |
| -   Odor                         |                              |    |
|                                  |                              |    |
| -   Induration                   |                              |    |
|                                  |                              |    |
| -   Cellulitis                   |                              |    |
+----------------------------------+------------------------------+----+
| For atypical and/or recalcitrant | (Labropoulos et al.,         | *  |
| wounds, rule out other, less     | \"Uncommon leg ulcers,\"     | *B |
| common causes of ulceration      | 2007)                        | ** |
| (biopsy may be necessary)        |                              |    |
|                                  |                              |    |
| -   Rheumatoid arthritis         |                              |    |
|                                  |                              |    |
| -   Sickle cell disease          |                              |    |
|                                  |                              |    |
| -   Pyogenic gangrenosum         |                              |    |
|                                  |                              |    |
| -   Tumors (squamous cell and    |                              |    |
|     basal cell carcinomas)       |                              |    |
+----------------------------------+------------------------------+----+
| **Additional Considerations:**   |                              |    |
+----------------------------------+------------------------------+----+
| Assess for confounding factors:  | (Wipke-Tevis et al., 2000;   | *  |
|                                  | Jelnes et al., 1986; Khan et | *B |
| -   Impaired tissue perfusion    | al., 2006; O\'Meara et al.,  | ** |
|     (heart disease, obesity)     | 2000)                        |    |
|                                  |                              |    |
| -   Tissue hypoxia               |                              |    |
|                                  |                              |    |
| -   Metabolic disturbances       |                              |    |
|     (diabetes, nephropathy)      |                              |    |
|                                  |                              |    |
| -   Impaired healing             |                              |    |
|                                  |                              |    |
| -   Immunosuppression            |                              |    |
|                                  |                              |    |
| -   Tobacco use                  |                              |    |
|                                  |                              |    |
| -   Infection (systemic and      |                              |    |
|     local)                       |                              |    |
|                                  |                              |    |
| -   Nutrition and overall state  |                              |    |
|     of health                    |                              |    |
+----------------------------------+------------------------------+----+
| Assess and document allergies    | (Saap et al., 2004; Lim et   | *  |
|                                  | al., 2007; Tavadia et al.,   | *B |
|                                  | 2003; Machet et al., 2004)   | ** |
+----------------------------------+------------------------------+----+
| Assess for the presence of       | (Shih, Shih, & Wong, 2005;   | *  |
| osteomyelitis:                   | Senneville et al., 2006)     | *B |
|                                  |                              | ** |
| -   Bone exposed (or easily      |                              |    |
|     probed)                      |                              |    |
|                                  |                              |    |
| -   Tissue necrosis overlying    |                              |    |
|     bone                         |                              |    |
|                                  |                              |    |
| -   Gangrene                     |                              |    |
|                                  |                              |    |
| -   Persistent sinus tract       |                              |    |
|                                  |                              |    |
| -   Underlying open fracture     |                              |    |
|                                  |                              |    |
| -   Underlying internal fixation |                              |    |
|                                  |                              |    |
| -   Wound recurrence             |                              |    |
|                                  |                              |    |
| Osteomyelitis evaluation:        |                              |    |
|                                  |                              |    |
| -   Radiographic studies (plain  |                              |    |
|     radiographs, nuclear bone    |                              |    |
|     scan and/or magnetic         |                              |    |
|     resonance imaging)           |                              |    |
|                                  |                              |    |
| -   If radiographic findings     |                              |    |
|     suggestive osteomyelitis,    |                              |    |
|     consider histologic          |                              |    |
|     evaluation and bone biopsy   |                              |    |
|     culture                      |                              |    |
+----------------------------------+------------------------------+----+
| Determine the presence of remote | (El-Ahdab et al., 2005)      | *  |
| site or systemic infection       |                              | *B |
| (septicemia, endocarditis,       |                              | ** |
| prosthesis infection):\          |                              |    |
| \                                |                              |    |
| Anatomic risk factors include:   |                              |    |
|                                  |                              |    |
| -   Prosthetic heart valve       |                              |    |
|                                  |                              |    |
| -   Acquired cardiac valvular    |                              |    |
|     dysfunction                  |                              |    |
|                                  |                              |    |
| -   Cardiac malformation         |                              |    |
|                                  |                              |    |
| -   Hypertrophic cardiomyopathy  |                              |    |
|                                  |                              |    |
| -   Orthopedic prosthesis        |                              |    |
|                                  |                              |    |
| -   Central nervous system (CNS) |                              |    |
|     shunts                       |                              |    |
|                                  |                              |    |
| -   Nearby arteriovenous fistula |                              |    |
+----------------------------------+------------------------------+----+
| Comorbid risk factors:           | (El-Ahdab et al., 2005)      | *  |
|                                  |                              | *B |
| -   History of bacterial         |                              | ** |
|     endocarditis                 |                              |    |
|                                  |                              |    |
| -   Immune compromised or        |                              |    |
|     suppressed host              |                              |    |
|                                  |                              |    |
| -   Colonization, multi-drug     |                              |    |
|     resistant organisms          |                              |    |
+----------------------------------+------------------------------+----+
| **Pain, Functional Status, and   | Expert Opinion               | *  |
| Quality of Life**                |                              | *D |
|                                  |                              | ** |
| -   Assess pain level (Visual    |                              |    |
|     Analog Scale)                |                              |    |
|                                  |                              |    |
| -   Validated questionnaires can |                              |    |
|     assess functional status and |                              |    |
|     quality of life              |                              |    |
+----------------------------------+------------------------------+----+

 

+-------------------------------------------+--------------------+----+
| **Recommendations for Treatment**         | **Supporting       | *  |
|                                           | Evidence**         | *G |
|                                           |                    | ra |
|                                           |                    | de |
|                                           |                    | ** |
+===========================================+====================+====+
| **Debridement**:                          | (Thow & Smith,     | *  |
|                                           | 2003; Smith, 2002; | *B |
| -   Excise all necrotic, infected, and    | Granick et al.,    | ** |
|     poorly vascularized soft tissue       | 2007)              |    |
|                                           |                    |    |
| -   May be necessary to perform serially  |                    |    |
|                                           |                    |    |
| -   Contraindicated in cases of gangrene  |                    |    |
|     or stable, dry, ischemic wound        |                    |    |
|     (evaluation of vascular status        |                    |    |
|     needed)                               |                    |    |
|                                           |                    |    |
| -   Sharp debridement not recommended if  |                    |    |
|     vasculitis or pyoderma gangrenosum is |                    |    |
|     suspected                             |                    |    |
|                                           |                    |    |
| -   Following debridement, consider       |                    |    |
|     irrigation with saline                |                    |    |
|                                           |                    |    |
| -   If tissue is suspect for malignancy,  |                    |    |
|     perform biopsy and submit for         |                    |    |
|     histopathologic analysis              |                    |    |
+-------------------------------------------+--------------------+----+
| **Pressure Relief**                       | (Duby et al.,      | *  |
|                                           | 1993; Cullum et    | *B |
| -   Implement established repositioning   | al., 2001; Cullum  | ** |
|     schedule                              | et al., 2004)      |    |
|                                           |                    |    |
| -   Head of the bed should be maintained  |                    |    |
|     at lowest possible level consistent   |                    |    |
|     with medical condition                |                    |    |
|                                           |                    |    |
| -   Use pressure-reducing devices         |                    |    |
+-------------------------------------------+--------------------+----+
| **Infection Control**                     | (Gentry et al.,    | *  |
|                                           | 1989; White,       | *B |
| -   Determine presence of invasive        | Cutting, &         | ** |
|     pathogens (culture and susceptibility | Kingsley, 2006;    |    |
|     testing of deep tissue sample;        | Nelson et al.,     |    |
|     clinical presentation of induration,  | 2006; Vermeulen et |    |
|     erythema, warmth, suppuration, and    | al., 2005;         |    |
|     pain or tenderness)                   | O\'Meara et al.,   |    |
|                                           | 2000; Vermeulen et |    |
| -   If infection is confirmed or highly   | al., 2007)         |    |
|     suspect, prescribe appropriate        |                    |    |
|     antimicrobial intervention (oral      |                    |    |
|     cephalosporins,                       |                    |    |
|     amoxicillin-clavulanic acid,          |                    |    |
|     macrolides, anti-staphylococcal       |                    |    |
|     penicillins, and fluoroquinolones can |                    |    |
|     be used; however, no evidence         |                    |    |
|     supports superiority of one over the  |                    |    |
|     others)                               |                    |    |
|                                           |                    |    |
| -   When determining the need for         |                    |    |
|     antibiotic treatment, consider risk   |                    |    |
|     of antibiotic resistance              |                    |    |
|                                           |                    |    |
| -   For mild to moderate infections,      |                    |    |
|     consider surgical debridement and     |                    |    |
|     narrow-spectrum antibacterials        |                    |    |
|                                           |                    |    |
| -   Wound infections that are severe      |                    |    |
|     and/or complicated by critical limb   |                    |    |
|     ischemia often necessitate            |                    |    |
|     hospitalization, parenteral           |                    |    |
|     broad-spectrum antibiosis, and        |                    |    |
|     surgical intervention                 |                    |    |
+-------------------------------------------+--------------------+----+
| **Management of Exudate**                 | (Embil et al.,     | *  |
|                                           | 2000; Vermeulen et | *B |
| -   Maintain moist environment            | al., 2005;         | ** |
|                                           | O\'Meara et al.,   |    |
| -   Remove soluble factors detrimental to | 2000; Vermeulen et |    |
|     wound healing                         | al., 2007; Bergin  |    |
|                                           | & Wraight, 2006;   |    |
| -   Use appropriate dressings (available  | Jones & Nelson,    |    |
|     evidence shows no superiority in      | 2007)              |    |
|     dressing materials)                   |                    |    |
|                                           |                    |    |
| -   Consider classic dressings (gauze,    |                    |    |
|     foam, hydrocolloid, hydrogels)        |                    |    |
|                                           |                    |    |
| -   Consider bioactive dressings (topical |                    |    |
|     antimicrobials, bioengineered         |                    |    |
|     composite skin equivalent, bilaminar  |                    |    |
|     dermal regeneration template,         |                    |    |
|     recombinant human growth factor)      |                    |    |
+-------------------------------------------+--------------------+----+

 

+-------------------------------------+--------------------------+----+
| **Recommendations for Management of | **Supporting Evidence**  | *  |
| Complications**                     |                          | *G |
|                                     |                          | ra |
|                                     |                          | de |
|                                     |                          | ** |
+=====================================+==========================+====+
| **Osteomyelitis**                   | (Henke et al., 2005;     | *  |
|                                     | Bach et al., 2007; Eren, | *B |
| -   Consider aggressive resection   | Ghofrani, & Reifenrath,  | ** |
|     of infected bone                | 2001; Embil et al.,      |    |
|                                     | 2006; Freeman et al.,    |    |
| -   Implement culture-directed      | 2007)                    |    |
|     antibiotic therapy              |                          |    |
|                                     |                          |    |
| -   Use well-perfused tissue        |                          |    |
|     (typically muscle) for coverage |                          |    |
+-------------------------------------+--------------------------+----+
| **Antibiotic Prophylaxis**          | (Henke et al., 2005)     | *  |
|                                     |                          | *B |
| -   Routine use of systemic         |                          | ** |
|     antimicrobials not recommended  |                          |    |
|     for prevention of               |                          |    |
|     osteomyelitis, bacterial        |                          |    |
|     endocarditis, or prosthesis     |                          |    |
|     infection                       |                          |    |
|                                     |                          |    |
| -   Endocarditis prophylaxis is     |                          |    |
|     indicated for high risk         |                          |    |
|     patients undergoing             |                          |    |
|     dermatologic procedures on      |                          |    |
|     visibly inflamed or infected    |                          |    |
|     wounds                          |                          |    |
+-------------------------------------+--------------------------+----+

 

+-------------------------------------------+--------------------+----+
| **Recommendations for Follow-up**         | **Supporting       | *  |
|                                           | Evidence**         | *G |
|                                           |                    | ra |
|                                           |                    | de |
|                                           |                    | ** |
+===========================================+====================+====+
| **Patient with Chronic Wounds:**          | Expert Opinion     | *  |
|                                           |                    | *D |
| -   Perform follow-up every month during  |                    | ** |
|     wound healing                         |                    |    |
|                                           |                    |    |
| -   Assess for systemic infection         |                    |    |
|                                           |                    |    |
| -   Assess pain, discuss pain reduction   |                    |    |
|     methods, and adjust pain medication   |                    |    |
|     accordingly                           |                    |    |
+-------------------------------------------+--------------------+----+
| **Patients with Venous Insufficiency**:   | (Baker et al.,     | *  |
|                                           | 1991; Berard et    | *B |
| -   During wound healing, weekly          | al., 2002;         | ** |
|     follow-up may be necessary            | Blomgren et al.,   |    |
|                                           | 2001)              |    |
| -   After wound healing, follow-up can be |                    |    |
|     performed every 3 to 6 months,        |                    |    |
|     depending on patient, comorbidities,  |                    |    |
|     and patient\'s ability for self care  |                    |    |
|                                           |                    |    |
| -   Patients with worsening symptoms may  |                    |    |
|     require more aggressive follow-up     |                    |    |
|     regimen                               |                    |    |
|                                           |                    |    |
| -   Perform physical exam of lower        |                    |    |
|     extremities (note changes in          |                    |    |
|     condition, skin color, temperature,   |                    |    |
|     tone, and hair, and presence of       |                    |    |
|     swelling; note new areas of skin      |                    |    |
|     breakdown or maceration)              |                    |    |
|                                           |                    |    |
| -   Order additional diagnostic studies   |                    |    |
|     (venous duplex, venography) as        |                    |    |
|     indicated                             |                    |    |
+-------------------------------------------+--------------------+----+
| **Patients with Peripheral Arterial       | (Stoffers et al.,  | *  |
| Disease**:                                | 1997; Stein et     | *B |
|                                           | al., 2006)         | ** |
| -   Assess activity level, pain, changes  |                    |    |
|     in skin temperature and color;        |                    |    |
|     inspect skin, pulses and capillary    |                    |    |
|     refill of the toes                    |                    |    |
|                                           |                    |    |
| -   Obtain ABI, which may indicate        |                    |    |
|     angiography                           |                    |    |
|                                           |                    |    |
| -   If necessary, refer to vascular       |                    |    |
|     surgeon or interventional radiologist |                    |    |
+-------------------------------------------+--------------------+----+
| **Patients with Diabetes**:               | (Dormandy &        | *  |
|                                           | Murray, 1991;      | *B |
| -   Physical exam should include          | Jelnes et al.,     | ** |
|     assessment of comorbidities (presence | 1986; Pham et al., |    |
|     of bone infections, peripheral        | 2000; Dolan et     |    |
|     vascular disease, neuropathy, and     | al., 2002)         |    |
|     multiple recurrences)                 |                    |    |
|                                           |                    |    |
| -   Evaluate patient\'s blood sugars,     |                    |    |
|     diet, and exercise                    |                    |    |
|                                           |                    |    |
| -   Assess skin for pressure points,      |                    |    |
|     ischemic changes, and skin maceration |                    |    |
|                                           |                    |    |
| -   Check prosthetics or shoes for        |                    |    |
|     abnormal wear                         |                    |    |
|                                           |                    |    |
| -   Assess for peripheral vascular        |                    |    |
|     disease (ABI \<0.08)                  |                    |    |
|                                           |                    |    |
| -   Assess for osteomyelitis              |                    |    |
|                                           |                    |    |
| -   Order laboratory studies (glycated    |                    |    |
|     hemoglobin \[HbA1c\], fasting         |                    |    |
|     glucose, lipid profile)               |                    |    |
|                                           |                    |    |
| -   If patients have increase risk for or |                    |    |
|     have diabetic neuropathy, assess for  |                    |    |
|     friction or pressure injuries         |                    |    |
|                                           |                    |    |
| -   Patients with diabetic neuropathy     |                    |    |
|     should be seen every 3 months for     |                    |    |
|     assessment of skin trauma and early   |                    |    |
|     breakdown                             |                    |    |
|                                           |                    |    |
| -   Assess for chronic pain and consider  |                    |    |
|     referral to pain specialist           |                    |    |
+-------------------------------------------+--------------------+----+
| **Patients with History of                | Expert Opinion     | *  |
| Osteomyelitis**:                          |                    | *D |
|                                           |                    | ** |
| -   Perform follow-up every month during  |                    |    |
|     wound healing                         |                    |    |
|                                           |                    |    |
| -   Perform follow-up every 3-6 months to |                    |    |
|     evaluate for recurrence of            |                    |    |
|     osteomyelitis                         |                    |    |
|                                           |                    |    |
| -   Evaluate lower extremities to         |                    |    |
|     determine need for further tests      |                    |    |
|                                           |                    |    |
| -   Consider laboratory studies           |                    |    |
|     (erythrocyte sedimentation rate       |                    |    |
|     \[ESR\], C-reactive protein \[CRP\])  |                    |    |
|                                           |                    |    |
| -   Consider x-rays, magnetic resonance   |                    |    |
|     imaging (MRI), or bone scans,         |                    |    |
|     depending on symptoms                 |                    |    |
+-------------------------------------------+--------------------+----+

 

+-------------------------------+--------------------------------+----+
| **Recommendations for         | **Supporting Evidence**        | *  |
| Prevention of Recurrence**    |                                | *G |
|                               |                                | ra |
|                               |                                | de |
|                               |                                | ** |
+===============================+================================+====+
| **Patient Education**:        | Expert Opinion                 | *  |
|                               |                                | *D |
| -   Long-term nature of       |                                | ** |
|     condition                 |                                |    |
|                               |                                |    |
| -   Signs/symptoms of         |                                |    |
|     recurrence                |                                |    |
|                               |                                |    |
| -   Skin care (soaps,         |                                |    |
|     moisturizers, protective  |                                |    |
|     measures)                 |                                |    |
+-------------------------------+--------------------------------+----+
| **Therapeutic Modalities**:   | (Duby et al., 1993; Cullum et  | *  |
|                               | al., 2001; Cullum et al.,      | *B |
| -   For patients with venous  | 2004; Cullum et al.,           | ** |
|     hypertension or risk for  | \"Compression for venous leg   |    |
|     venous insufficiency,     | ulcers,\" 2000; Nelson,        |    |
|     consider Graduated        | Bell-Syer, & Cullum, 2000;     |    |
|     Compression Stockings     | Cullum et al., \"Compression   |    |
|                               | bandages,\" 2000; Ibegbuna et  |    |
| -   For patients with wounds  | al., 2003; Zajkowski et al.,   |    |
|     in pressure point areas,  | 2002)                          |    |
|     consider off-loading      |                                |    |
|     devices, pressure         |                                |    |
|     dispersing surfaces       |                                |    |
|                               |                                |    |
| -   For patients with wounds  |                                |    |
|     secondary to abnormal     |                                |    |
|     sensitivity or mobility,  |                                |    |
|     consider repositioning    |                                |    |
|     and support surfaces      |                                |    |
+-------------------------------+--------------------------------+----+
| **Exercise Programs           | Expert Opinion                 | *  |
| Improve**:                    |                                | *D |
|                               |                                | ** |
| -   Patient mobility          |                                |    |
|                               |                                |    |
| -   Joint movement            |                                |    |
+-------------------------------+--------------------------------+----+

**Definitions**:

**Scale for Grading Recommendations**

  -------------------------------------------------------------------------------
  **Grade**   **Descriptor**   **Qualifying     **Implications for Practice**
                               Evidence**       
  ----------- ---------------- ---------------- ---------------------------------
  A           Strong           Level I evidence Clinicians should follow a strong
              Recommendation   or consistent    recommendation unless a clear and
                               findings from    compelling rationale for an
                               multiple studies alternative approach is present.
                               of levels II,    
                               III, or IV       

  B           Recommendation   Levels II, III,  Generally, clinicians should
                               or IV evidence   follow a recommendation but
                               and findings are should remain alert to new
                               generally        information and sensitive to
                               consistent       patient preference.

  C           Option           Levels II, III,  Clinicians should be flexible in
                               or IV evidence,  their decision-making regarding
                               but findings are appropriate practice, although
                               inconsistent     they may set bounds on
                                                alternatives; patient preference
                                                should have a substantial
                                                influencing role.

  D           Option           Level V; little  Clinicians should consider all
                               or no systematic options in their decision-making
                               empirical        and be alert to new published
                               evidence         evidence that clarifies the
                                                balance of benefit versus harm;
                                                patient preference should have a
                                                substantial influencing role.
  -------------------------------------------------------------------------------

**Evidence Rating Scale for Diagnostic Studies**

  -------------------------------------------------------------------------
  **Level of   **Qualifying Studies**
  Evidence**   
  ------------ ------------------------------------------------------------
  I            High-quality, multi-centered or single-centered, cohort
               study validating a diagnostic test (with \"gold\" standard
               as reference) in a series of consecutive patients; or a
               systematic review of these studies

  II           Exploratory cohort study developing diagnostic criteria
               (with \"gold\" standard as reference) in a series of
               consecutive patients; or a systematic review of these
               studies

  III          Diagnostic study in nonconsecutive patients (without
               consistently applied \"gold\" standard as reference); or a
               systematic review of these studies

  IV           Case-control study; or any of the above diagnostic studies
               in the absence of a universally accepted \"gold\" standard

  V            Expert opinion; case report or clinical example; or evidence
               based on physiology, bench research, or \"first principles\"
  -------------------------------------------------------------------------

**Evidence Rating Scale for Prognostic Studies**

  ------------------------------------------------------------------------
  **Level of   **Qualifying Studies**
  Evidence**   
  ------------ -----------------------------------------------------------
  I            High-quality, multi-centered or single-centered,
               prospective cohort study with adequate power; or a
               systematic review of these studies

  II           Lesser-quality prospective cohort study; retrospective
               study; untreated controls from a randomized controlled
               trial; or a systematic review of these studies

  III          Case-control study; or a systematic review of these studies

  IV           Case series

  V            Expert opinion; case report or clinical example; or
               evidence based on physiology, bench research, or \"first
               principles\"
  ------------------------------------------------------------------------

**Evidence Rating Scale for Therapeutic Studies**

  -----------------------------------------------------------------------
  **Level of   **Qualifying Studies**
  Evidence**   
  ------------ ----------------------------------------------------------
  I            High-quality, multi-centered or single-centered,
               randomized controlled trial with adequate power; or a
               systematic review of these studies

  II           Lesser-quality, randomized controlled trial; prospective
               cohort study; or a systematic review of these studies

  III          Retrospective comparative study; case-control study; or a
               systematic review of these studies

  IV           Case series

  V            Expert opinion; case report or clinical example; or
               evidence based on physiology, bench research, or \"first
               principles\"
  -----------------------------------------------------------------------

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=11513)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate treatment and management of chronic wounds of the lower
extremity

#### POTENTIAL HARMS

-   Overuse of antibiotics for uncomplicated soft tissue infections
    risks tangible harm by promoting antimicrobial resistance.

-   There is a risk of contact dermatitis following the use of topical
    antibiotics.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Debridement is contraindicated in the presence of dry gangrene or a
stable, dry ischemic wound until vascular status is evaluated. If
vasculitis or pyoderma gangrenosum is suspected, sharp debridement is
not recommended.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   Clinical practice guidelines are strategies for patient management
    and are developed to assist physicians in clinical decision making.
    This guideline, based on a thorough evaluation of the scientific
    literature and relevant clinical experience, describes a range of
    generally acceptable approaches to diagnosis, management, or
    prevention of specific diseases or conditions. This guideline
    attempts to define principles of practice that should generally meet
    the needs of most patients in most circumstances.

-   However, this guideline should not be construed as a rule, nor
    should it be deemed inclusive of all proper methods of care or
    exclusive of other methods of care reasonably directed at obtaining
    the appropriate results. It is anticipated that it will be necessary
    to approach some patients\' needs in different ways. The ultimate
    judgment regarding the care of a particular patient must be made by
    the physician in light of all circumstances presented by the
    patient, the available diagnostic and treatment options, and other
    available resources.

-   This guideline is not intended to define or serve as the standard of
    medical care. Standards of medical care are determined on the basis
    of all facts or circumstances involved in an individual case and are
    subject to change as scientific knowledge and technology advance,
    and as practice patterns evolve. This guideline reflects the state
    of knowledge current at the time of publication. Given the
    inevitable changes in the state of scientific information and
    technology, periodic review, updating and revision will be done.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

American Society of Plastic Surgeons. Evidence-based clinical practice
guideline: chronic wounds of the lower extremity. Arlington Heights
(IL): American Society of Plastic Surgeons; 2007 May. 21 p. \[132
references\]

#### ADAPTATION

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

#### DATE RELEASED

2007 May

#### GUIDELINE DEVELOPER(S)

American Society of Plastic Surgeons - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Society of Plastic Surgeons

#### GUIDELINE COMMITTEE

Health Policy Committee of the American Society of Plastic Surgeons

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American Society of Plastic Surgeons Web
site](http://www.plasticsurgery.org/medical_professionals/health_policy/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=26863).

Print copies: Available from the American Society of Plastic Surgeons,
444 East Algonquin Road, Arlington Heights, IL 6005-4664

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   Description and development of evidence-based practice guidelines.
    American Society for Plastic Surgeons. Electronic copies: Available
    from the [American Society of Plastic Surgeons Web
    site](http://www.plasticsurgery.org/medical_professionals/health_policy/Evidence-Based-Clinical-Practice-Guidelines.cfm).

Print copies: Available from the American Society of Plastic Surgeons,
444 East Algonquin Road, Arlington Heights, IL 6005-4664

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on October 15, 2007.
The information was verified by the guideline developer on October 23,
2007. This summary was updated by ECRI Institute on July 28, 2008
following the U.S. Food and Drug Administration advisory on
fluoroquinolone antimicrobial drugs.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
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<http://www.guideline.gov/about/inclusion.aspx> .

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Date Modified: 11/3/2008