VenUS I: a randomised controlled trial of two types of bandage for treating venous leg ulcers.

OBJECTIVES: To compare the clinical and cost-effectiveness of two different compression bandages for the healing of venous leg ulcers.

DESIGN: A pragmatic, randomised controlled trial with an economic evaluation.

SETTING: Community, district nurse-led services; community leg ulcer clinics; hospital leg ulcer clinics with community outreach. A range of urban and rural settings in England and Scotland.

PARTICIPANTS: Patients with a venous leg ulcer of at least 1-week's duration, at least 1 cm in length or width and an ankle:brachial pressure index of at least 0.8.

INTERVENTIONS: The four-layer bandage (4LB) (which is multilayer elastic compression) compared with the short-stretch bandage (SSB) (multilayer, inelastic compression).

MAIN OUTCOME MEASURES: The primary end-point was complete healing of all the ulcers on the trial leg. Secondary outcomes were the proportion of patients healed at 12 and 24 weeks, rate of recurrence, costs of leg ulcer treatment and quality of life.

RESULTS: Between April 1999 and December 2000 the trial recruited 387 people aged from 23 to 97 years at trial entry. The majority of patients in this trial (82%; 316/387) had a reference ulcer of area
CONCLUSIONS: The 4LB, which is currently the UK standard compression bandage for people with venous leg ulcers, was more clinically and cost-effective than the SSB. The bandage costs were less important than the costs of treatment visits, and patients in SSBs required more treatment overall. Generally, this trial supports the use of the 4LB in preference to the SSB. Recommendations for future research include: exploration of the relationship between bandager skill, application technique and ulcer healing; the relative cost-effectiveness of community leg ulcer clinics; and the study of nurse decision-making in venous ulcer management.