Bibliographic Source(s)

• Association for the Advancement of Wound Care (AAWC). Summary algorithm for venous ulcer care with annotations of available evidence. Malvern (PA): Association for the Advancement of Wound Care (AAWC); 2005. 25 p. [147 references]

Guideline Status

This is the current release of the guideline.

Guideline Category

Diagnosis
Evaluation
Management
Treatment

Intended Users

Advanced Practice Nurses
Health Care Providers
Health Plans
Hospitals
Managed Care Organizations
Nurses
Occupational Therapists
Patients
Pharmacists
Physical Therapists
Physician Assistants
Physicians
Podiatrists
Public Health Departments
Students
Substance Use Disorders Treatment Providers
Utilization Management

Guideline Objective(s)

• To identify best practice wound management modalities
• To explore reimbursement of evidence-based practices in various health care settings
• To close evidence and reimbursement gaps

Target Population

All patients with venous ulcer(s)

Interventions and Practices Considered

Diagnosis

1. Patient history
2. Differential diagnosis
3. Physical examination

Management

1. Patient education
2. Lower leg elevation
3. Ambulation/exercise
4. Compression
5. Peri-wound skin care
6. Cleanse wound
7. Necrotic tissue debridement
8. Filling of deep wounds
9. Management of excess exudate
10. Maintenance of moist wound environment
11. Antimicrobial wound care
12. Biologic dressings
13. Skin replacement
14. Biophysical modalities
15. Pharmacotherapy
16. Closure obliteration or surgical repair of veins

Major Outcomes Considered

• Ulcer healing rate and time
• Ulcer recurrence
• Accuracy of diagnostic tests
• Adverse effects of treatment
• Symptom relief

Methods Used to Collect/Select Evidence

Searches of Electronic Databases

Description of Methods used to Collect/Select the Evidence

MEDLINE and EMBASE databases were searched to identify and list up to five of the best published support references for each step in the algorithm.

Number of Source Documents

210

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

Strength of Evidence Ratings

1. Results of two or more randomized controlled trials (RCTs) in humans provide support (or for diagnostics or risk analysis: cohort [CO] studies).
2. Results of two or more historically controlled trials (HCTs) or convenience assignment or non-randomized controlled trials (CCTs) or a CCT and an RCT in humans provide support or when appropriate results of two or more controlled trials in an animal model provide indirect support.
3. This rating requires one or more of the following:
   1. Results of one controlled trial (e.g. RCT or CCT or HCT)
   2. Results of at least two case series (CS) or descriptive studies or a cohort study in humans
   3. Expert opinion (EO)

Methods Used to Analyze the Evidence

Systematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

The Task Force inclusively summarized algorithms for venous ulcer management published before August 2002. The current evidence level for each item in the algorithm was listed in parentheses after the item. A-level evidence is highest and C-level evidence is lowest: e.g. expert opinion. Criteria for quality of support were developed based on those previously used by the Agency for Healthcare Policy and Research (AHCPR) (now Agency for Health Research and Quality [AHRQ]) for Clinical Practice Guideline #15: Treatment of Pressure Ulcers (AHCPR Publication No. 95-0652). The scheme is summarized in the "Rating Scheme for the Strength of the Evidence." Appendix I of the Annotated Venous Ulcer Algorithm summarizes the evidence the Task Force found to this date.

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

The Task Force first inclusively summarized algorithms for venous ulcer management published before August 2002 and then searched the literatures to identify and list up to five of the best published support references for each step in the algorithm.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

The guideline developers reviewed published cost analyses of venous ulcer care. Refer to the annotations accompanying the Annotated Venous Ulcer Algorithm for short summaries of these studies.

Method of Guideline Validation

Peer Review

Description of Method of Guideline Validation

Algorithm Content Validation

The Task Force conducted a formal content validity study for these algorithms which is currently being prepared for publication. The clinical validity or relevance of the individual items in the algorithm were rated in order of appearance in the Annotated Venous Ulcer Algorithm by 16 multi-disciplinary wound care professionals using the 4-point Likert scale below:

1 = Not relevant

2 = Unable to assess relevance without further information

3 = Relevant but needs minor attention

4 = Very relevant and succinct

Items with an evidence level A or average score more than 3.5 remained unchanged and were deemed to have content validity. Those with average item relevance 2.5 to 3.5 were modified as recommended in a separate comment section. Those with a score less than 2.5 were deleted from the algorithm as not content validated for venous ulcer care.

Major Recommendations

Strength of evidence ratings (A-C) are defined at the end of the "Major Recommendations" field.

1. Venous ulcer diagnosis consisting of:
   1. Patient history
      • Prior phlebitis deep vein thrombosis (DVT) C (Aharinejad et al. 2001; Berard et al. 2002 Nicolaides et al. 2000)
      • Lower leg swelling/edema A (Duby et al. 1993; Wipke-Tevis et al. 2000; Shebel 2002)
      • Ache or tiredness in leg C
      • Trauma/intimal damage C (Nicolaides et al. 2000)
      • Maternal venous ulcer C (Berard et al. 2002)
      • Vigorous exercise C (Berard et al. 2002)
      • Hypercoagulation B (Blomgren et al. 2001; Fink et al. 2002)
      • Multiple pregnancy C (Berard et al. 2002)
   2. Differential diagnosis
      • Doppler ankle: brachial index A (McGuckin et al. 2002; Bjellerup 2003; Kazmers et al. 1996; Ghauri et al. 1998)
      • Duplex scanning ultrasound B (Yosadhara et al. 2003; Labropoulos Landon & Jay 2002)
      • Plethysmography A (Alexanderhouse Group 1992; Cordts et al 1992; Garcia-Rinaldi et al. 2002; Perrin Hiltbrand & Bayott 1999; Ghauri et al. 1998)
      • Ambulatory venous flow or refill time B (Yosadhara et al. 2003; Heit et al. 2001; Nelzen et al. 1991; Phillips 1999)
      • Transcutaneous PO₂ A (Stacey et al. 1990; Alexanderhouse Group 1992)
      • Elevated temperature C
      • Factor VIII related antigen C (Wilkinson Emery & Palmer 1990)
   3. Physical exam
      • Clinical severity etiology anatomy pathophysiology (CEAP) A (Navarro Konstantinos & Ribeiro 2002; Carpentier et al. 2003; Kalodiki & Nicolaides 2002)
      • Edema A (Burton 1993; Duby et al. 1993; Ennis & Meneses 1995; Lippmann et al. 1994; Shebel 2002)
      • Stasis dermatitis C (Alguire et al. 1997; Cherry et al. 1993)
      • Hemosiderin C (Burton 1993)
      • Lipodermatosclerosis C (Kirsner et al.1993)
      • Medial lower leg site A (McGuckin et al. 2002; Phillips 1999)
      • Varicosities C (Weiss 1995)
      • Measure ulcer size A (McGuckin et al. 2002; Kantor & Margolis 2000; van Rijswijk 1993)

2. Remove ulcer cause or address ulcer etiology by aiding venous return and providing skin care
   1. Patient education A (McGuckin et al. 2002; Shebel 2002; Stacey et al 2002.)
   2. Lower leg elevation C (Alexanderhouse Group 1992; Kerstein et al. 2001)
   3. Ambulation or exercise C (Alexanderhouse Group 1992; Kerstein et al. 2001)
      • Use a multidisciplinary team C (Lee et al. 2004)
   4. Compression options
      • Elastic compression bandage heals more than inelastic compression A (Blair et al. 1988; Cullum Nelson & Fletcher 2002; Callam et al. 1992; Gould 1998; Northeast et al. 1990)
      • Multi-layer (2 3 or 4 layers) sustained elastic high-compression bandage A (Cullum Nelson & Fletcher 2002; Charles 1991; Callam et al. 1992; Gould et al. 1998; Meyer et al. 2003; Patel et al. 2004; Vowden et al. 2000; Wilson et al. 2002)
      • Elastic high-compression stockings to heal venous ulcers A (Benigni et al. 2003; Horakova & Partsch & Horakova 1994; Korn et al. 2002; Partsch & Horakova 1994; Johnson et al. 1982; Veraart & Neumann 1996; Morrell et al. 1998).
      • Elastic multiple-layer high-compression stockings to heal venous ulcers A (Mayberry et al. 1991; Polignano Guarnera & Bonadeo 2004; Samson & Showalter 1996; Samson 1993).
      • Duke Boot or Unna Boot + elastic compression A (Arnold & Stanly 1994; Burton 1993; Lyon et al. 1998; Eriksson 1986; Eriksson et al. 1984; Lippmann et al. 1994.
      • Gradient compression better than uniform compression C (Sigel et al. 1975)
      • Short stretch bandage A (Duby et al. 1993; Charles 1991; Gould et al. 1998; Charles 2002).
      • Unna boot zinc paste impregnated bandage A (Kitka et al. 1988; Rubin et al. 1990; Sikes 1985; DePalma et al. 1999).
      • Intermittent pneumatic compression A (Pekanmaki et al. 1991; Smith et al. 1990; Mani Vowden & Nelson 2001).
      • Non-elastic compression with Circaid B (Spence & Cahall 1996; Villavicencio 1994)
      • Sequential-gradient pneumatic compression C (Smith et al. 1990)
   5. Manage peri-wound skin
      • Moisturize C
      • Protect C
      • Manage peri-ulcer inflammation edema and circulation B (Myers Rightor & Cherry 1972; Mayrovitz & Larsen 1994; Wilson et al. 1991)
      • Manage peri-wound skin infection C

3. Local Wound Care
   1. Cleanse wound with safe cleanser 8-15 psi C
   2. Debride necrotic tissue
      • Sharp C (Donati et al. 1994)
      • Enzymatic B (Bergemann et al. 1999; Romanelli 1997)
      • Autolytic A (Romanelli 1997; Mulder et al. 1993)
      • Mechanical C (Donati et al. 1994)
   3. Fill deep wounds (C) (Beitz & van Rijswijk 1999)
   4. Manage excess exudate
      • Alginate A (Armstrong & Ruckley 1997; Bergemann et al. 1999; Ingram Wright & Ingoldby 1998; Lyon et al. 1998; Sayag Meaume & Bohbot 1996)
      • Hydrofiber A (Armstrong & Ruckley 1997; Harding et al. 2001; Quintinal 1999)
      • Foam dressings C (Pessenhoffer & Stangl 1989; Samson 1993)
      • Composite dressing AB (Daniels et al. 2002; Jones 2003; Vanscheidt Sibbald & Eager 2004)
   5. Maintain moist wound environment for healing or venous ulcer (VU) pain management
      • Hydrocolloid A (Arnold & Stanley 1994; Bergemann et al. 1999; Charles 1991; Charles 2002; Cordts et al. 1992; Eriksson 1986; Friedman & Su 1984; Kerstein et al. 2001; Koksal & Bozkurt 2003)
      • Hydrogel B (Romanelli 1997)
      • Film dressings B (Davis McCulloch & Neal 1992)
   6. Antimicrobial wound care if no healing is seen in 30 days
      • Limit systemic antibiotics to known identified pathogens C (Centers for Disease Control and Prevention [CDC])
      • Iodine-containing dressings A (Hilstrom 1888; Holloway et al. 1989; Hansson et al. 1998)
      • Silver-containing dressing C (Sibbald et al. 2001)
   7. Biologic dressings if no healing is seen in 30 days
      • Collagen/collagen combinations C (Vin Teot & Meaume 2002)
      • Hyaluronic acid or other matrix molecular dressings C (Ortonne 1996)
   8. Surgical options to cover wound if no healing is seen in 30 days
      • Skin replacement
        • Split-thickness or cultured autografts B (Turcynski & Tarpila 1999; Puonti & Asko-Seljavaara 1998)
        • Pinch grafts B (Christiansen Ek & Tegner 1997; Oein Hansen & Hakansson 1998)
        • Cultured epidermal autografts C
        • Allografts C (Mosti et al. 2002; Bolivar-Flores & Kuir-Harcuch 1999; Lindgren Marcusson & Toftgard. 1998)
        • Bioengineered skin B (Falanga et al. 1998; Kirsner et al. 1993; Brem et al. 2001; Brassard 2002)

4. Other modalities to apply if conservative therapy does not work in 30 days
   1. Biophysical modalities
      • Electrical stimulation A (Feedar Kloth & Gentzkow 1991; Houghton et al. 2003; Kloth & Feedar 1988)
      • Vacuum (Negative Pressure) B (Evans & Land 2002; Argenta & Morykwas 1997; Morykwas et al. 1997)
      • Warming C (Robinson & Santilli 1998; Santill et al. 1999)
      • Electromagnetic/radiofrequency (RF) stimulation A (Kenkre et al. 1996; Stiller et al. 1992; Jeran et al. 1990; Todd et al. 1991)
      • Laser C (Flemming & Cullum "Laser therapy" 2002)
      • Infrared (IR) stimulation (e.g. monochromatic) C
      • Hyperbaric oxygen C (Hammarlund & Sundberg 1994; Fischer 1975)
      • Ultrasound stimulation B (Flemming & Cullum "Therapeutic ultrasound" 2002; Lundberg et al. 2000; Callam et al. 1987)
      • Whirlpool C (McCulloch & Boyd 1992)
   2. Pharmaceutical modalities
      • Defibrotide C (Jull Waters & Arroll 2002)
      • Platelet derived growth factor C (Wieman 2003)
      • Trental (pentoxifylline) A (Falanga et al. 1998; Jull Waters & Arroll 2002)
      • Stanozolol C (Stacey et al. 1990)
      • Acetylsalicylic acid/aspirin C (Layton et al. 1994)
      • Solcoseryl (topical + systemic) C (Biland et al. 1985)
   3. Vein closure
      • Laser coagulation C
      • Sclerotherapy C
   4. Corrective vascular surgery
      • Subfascial endoscopic perforating vein surgery with ligation and stripping (SEPS) A (Barwell et al. 2004; TenBrook et al. 2004; Tawes et al. 2003)
      • Superficial vein surgery A (Barwell et al. 2004; Bello et al. 1999; Stacey 2001)
      • Valve repair or reconstruction B (Perrin Hiltbrand & Bayott 1999; Raju & Fredericks 1988; Jessup & Lane 1988)
      • Transplant or graft valve C (Garcia-Rinaldi et al. 2002)

5. Local wound care (under C above) until healed A (Kerstein 1996; Mayberry et al. 1991; McGuckin et al. 2002)
6. Compression elevation ambulation post healing to prevent recurrence A (Alexanderhouse Group 1992; Kerstein 1996; Mayberry et al. 1991; Veraart & Neumann 1996; McGuckin et al. 2002; Nelson Bell-Syer & Cullum 2003; Samson & Showalter 1996; Stacey et al. 2002).

Definitions:

Strength of Evidence Ratings

1. Results of two or more randomized controlled trials (RCTs) in humans provide support (or for diagnostics or risk analysis: cohort (CO) studies)
2. Results of two or more historically controlled trials (HCTs) or convenience assignment or non-randomized controlled trials (CCTs) or a CCT and a RCT in humans provide support or when appropriate results of two or more controlled trials in an animal model provide indirect support.
3. This rating requires one or more of the following:
   1. Results of one controlled trial (e.g. RCT or CCT or HCT)
   2. Results of at least two case series (CS) or descriptive studies or a cohort study in humans
   3. Expert opinion (EO)

Clinical Algorithm(s)

The original guideline document contains the "Annotated Venous Ulcer Algorithm."

References Supporting the Recommendations

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Type of Evidence supporting the Recommendations

The type of evidence supporting each recommendation is identified and graded (see the "Major Recommendations" field). Appendix 1 of the original guideline document lists the references and summarizes the evidence supporting each item in the algorithm.

Potential Benefits

Appropriate venous ulcer care leads to decreased healing times and increased healing rates and improves patient quality of life.

Potential Harms

Side effects of treatments and medications

Qualifying Statements

The Annotated Venous Ulcer Algorithm is not a comprehensive literature review. Rather it is a compendium of objectively rated best currently available evidence that the Task Force assembled supporting venous ulcer care identified in the combined venous ulcer algorithms summarized from the literature. The Task Force plans to update the literature search annually. The Annotated Venous Ulcer Algorithm is intended for use as a framework for identifying elements of venous ulcer care supported by the best currently available evidence and for highlighting gaps in knowledge supporting venous ulcer clinical practice which represent opportunities for further research.

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools

Clinical Algorithm

For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.

IOM Care Need

Getting Better
Living with Illness

IOM Domain

Effectiveness
Patient-centeredness

Bibliographic Source(s)

• Association for the Advancement of Wound Care (AAWC). Summary algorithm for venous ulcer care with annotations of available evidence. Malvern (PA): Association for the Advancement of Wound Care (AAWC); 2005. 25 p. [147 references]

Adaptation

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

Source(s) of Funding

Association for the Advancement of Wound Care

Guideline Committee

Not stated

Composition of Group that Authored the Guideline

Task Force Members: S. Alter DPM; A. Batzler MN FNP; D. L. Bernato RN MN WOCN; L. Bolton Ph.D.; N.R. Bruno RN BSN CETN; G. Chudleigh MS PT CWS; L. Corbett APRN MSNCWOCN; P. DotsonRN BSN; P. Erwin-Toth RN MSN CWOCN; G. Everhart DPT; R.S. Jordan RN BSN CWOCN; S.N. LaRaus PT CWS; S.K. Lee MD FACS; C.H. Lyder ND APRN CS GNP; P. McNees PhD; D.Merkle APRNMSN MSHSA CWOCN; T. Mulloy BSNRNCETN; M. Nusgart RPh; G.K. Patterson MD; T. Phillips MD; L. Dahl Popkes RN CWOCN; P. Porter Riedesel PT CWS; P. Sheehan MD; S. Sinkovic RN BSN CWOCN; M. Southworth MD

Financial Disclosures/Conflicts of Interest

Some members of this task force have conducted industry-supported research on venous ulcers with various product categories listed in the algorithm.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Association for the Advancement of Wound Care Web site.

Print copies: Available from the Association for the Advancement of Wound Care 83 General Warren Blvd. Suite 100 Malvern PA 19355

Availability of Companion Documents

None available

Patient Resources

None available

NGC STATUS

This NGC summary was completed by ECRI on July 29 2005. The information was verified by the guideline developer on August 15 2005.

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