Clinical Evidence Concise - April 1, 2005 - American Family Physician

Clinical Evidence Concise

A Publication of BMJ Publishing Group

Venous Leg Ulcers

E. ANDREA NELSON, PH.D., Health and Sciences University of York, York, United Kingdom

NICKY CULLUM, PH.D., Health and Sciences University of York, York, United Kingdom

JUNE JONES, M.Sc., Southport and Formby PCT, Southport, United Kingdom

What are the effects of treatments?

beneficial

Compression Bandages and Stockings. Two systematic reviews and one subsequent randomized controlled trial (RCT) found that compression bandages or stockings healed more venous leg ulcers than no compression. We found insufficient evidence from the reviews and two subsequent RCTs to compare multilayer elastomeric versus nonelastomeric high-compression bandages, or multilayer elastomeric high-compression versus short-stretch bandages. One systematic review found that multilayer compression increased ulcer healing compared with single-layer bandages. One systematic review and two subsequent RCTs found little evidence that any particular multilayer high-compression regimen was more effective than any other. We found insufficient evidence from one small RCT about the effects of compression bandages compared with intermittent pneumatic compression.

Oral Pentoxifylline. One systematic review and two subsequent RCTs found that oral pentoxifylline increases the proportion of ulcers healed over six to 12 months compared with placebo.

likely to be beneficial

Cultured Allogenic Bilayer Skin Replacement. One RCT found that cultured allogenic bilayer skin replacement increased the proportion of ulcers healed after six months compared with a nonadherent dressing.

Oral Flavonoids. Two RCTs found that adding flavonoids to compression increased the proportion of ulcers healed after two to six months compared with compression alone.

Oral Sulodexide. Two RCTs found that sulodexide plus compression increased the proportion of ulcers healed after two to three months of treatment compared with compression alone.

Peri-Ulcer Injection of Granulocyte-Macrophage Colony Stimulating Factor. One RCT found that peri-ulcer injection of granulocyte-macrophage colony stimulating factor increased the proportion of ulcers healed after 13 weeks of treatment compared with placebo.

Systemic Mesoglycan. One RCT found that systemic mesoglycan plus compression increased the proportion of ulcers healed after 24 weeks of treatment compared with compression alone.

unknown effectiveness

Debriding Agents; Foam, Film, or Alginate (Semi-Occlusive) Dressings Versus Simple Dressings in the Presence of Compression; Intermittent Pneumatic Compression; Laser (Low Level); Oral Aspirin; Oral Rutosides; Oral Thromboxane Alpha2 Antagonists; Oral Zinc; Skin Grafting; Topical Antimicrobial Agents; Topical Calcitonin Gene-Related Peptide Plus Vasoactive Intestinal Polypeptide; Topical Recombinant Keratinocyte Growth Factor 2; Topical Mesoglycan; Topical Negative Pressure; Ultrasound; Vein Surgery. RCTs provided insufficient evidence about the effects of these interventions on ulcer healing.

unlikely to be beneficial

Hydrocolloid Dressings (in the Presence of Compression, No Significant Difference in Healing Compared with Simple Low-Adherent Dressings). One systematic review found that, in the presence of compression, hydrocolloid dressings did not heal more venous leg ulcers than simple, low adherent dressings.

Topically Applied Autologous Platelet Lysate. One RCT found no significant difference in the proportion of people with healed ulcers after nine months between topically applied autologous platelet lysate and placebo.

What are the effects of interventions to prevent recurrence?

beneficial

Compression Stockings. RCTs found that compression reduced recurrence at six months compared with no compression, but noncompliance with compression is a risk factor for recurrence.

trade-off between benefits and harms

Vein Surgery. Two RCTs provided limited evidence that vein surgery with or without compression reduced recurrence compared with compression alone. Vein surgery has the usual risks of surgery and anesthesia.

unknown effectiveness

Oral Rutoside; Oral Stanozolol. RCTs provided insufficient evidence about the effects of these interventions on ulcer recurrence.

Definition

Definitions of leg ulcers vary, but the following is used widely: loss of skin on the leg or foot that takes more than six weeks to heal. Some definitions exclude ulcers confined to the foot, whereas others include ulcers on the whole of the lower limb. This review deals with ulcers of venous origin in people without concurrent diabetes mellitus, arterial insufficiency, or rheumatoid arthritis.

Incidence/Prevalence

One and one half to three of every 1,000 people have active leg ulcers. Prevalence increases with age to about 20 instances per 1,000 people older than 80 years.1

Etiology/Risk Factors

Leg ulceration is strongly associated with venous disease. However, about one fifth of people with leg ulceration have arterial disease, alone or in combination with venous problems, which may require subspecialist referral.1 Venous ulcers (also known as varicose or stasis ulcers) are caused by venous reflux or obstruction, both of which lead to poor venous return and venous hypertension.

Prognosis

People with leg ulcers have a poorer quality of life than age-matched controls because of pain, odor, and reduced mobility.2 In the United Kingdom, audits have found wide variation in the types of care (i.e., hospital inpatient care, hospital clinics, outpatient clinics, home visits), treatments used (i.e., topical agents, dressings, bandages, stockings), healing rates, and recurrence rates
(26 to 69 percent in one year).3,4

search date: November 2003

editor's note: Sulodexide, mesoglycan, thromboxane alpha2 antagonists, calcitonin gene-related peptide, vasoactive intestinal polypeptide, recombinant keratinocyte growth factor 2, hydrocolloid dressings, and autologous platelet lysate are not available in the United States. The U. S. Food and Drug Administration does not regulate rutosides.

Adapted with permission from Nelson EA, Cullum N, Jones J. Venous leg ulcers. Clin Evid Concise 2004;12:529-31.

Andrea Nelson and Nicky Cullum are applicants on a randomized controlled trial of compression bandages for which Beirsdorf UK Ltd. provided RCT-related education. All three authors have published systematic reviews included in this review.

REFERENCES

1. Callam MJ, Ruckley CV, Harper DR, et al. Chronic ulceration of the leg: extent of the problem and provision of care. BMJ 1985;290:1855-6.

2. Roe B, Cullum N, Hamer C. Patients' perceptions of chronic leg ulceration. In: Cullum N, Roe B, eds. Leg ulcers: nursing management. Harrow, England: Scutari, 1995:125-34.

3. Roe B, Cullum N. The management of leg ulcers: current nursing practice. In: Cullum N, Roe B, eds. Leg ulcers: nursing management. Harrow, England: Scutari, 1995:113-24.

4. Vowden KR, Barker A, Vowden P. Leg ulcer management in a nurse-led, hospital-based clinic. J Wound Care 1997;6:233-6.

This is one in a series of chapters excerpted from Clinical Evidence Concise, published by the BMJ Publishing Group, Tavistock Square, London, United Kingdom. Clinical Evidence Concise is published in print twice a year and is updated monthly online. Each topic is revised every 12 months, and subscribers should view the most up-to-date version at http://www.clinicalevidence.com. If you are interested in contributing to Clinical Evidence, please contact Klara Brunnhuber (kbrunnhuber@bmjgroup.com). This series is part of the AFP's CME. See "Clinical Quiz.".

This clinical content conforms to AAFP criteria for evidence-based continuing medical education (EB CME). EB CME is clinical content presented with practice recommendations supported by evidence that has been systematically reviewed by an AAFP-approved source. The evidence is available at http://www.clinicalevidence.com/ceweb/conditions/wnd/1902/1902.jsp.