Lothian and Forth Valley Leg Ulcer Healing Trial, Part 1: Elastic versus Non-Elastic Bandaging in the Treatment of Chronic Leg Ulceration

Abstract

Objective: To determine whether elastic or non-elastic bandaging is more effective in healing chronic venous ulcers. Design: Randomized trial with factorial design and interaction analysis, enabling independent evaluation of both bandaging and dressings within the single-trial format. The duration of treatment was 12 weeks or until ulcer-healing, whichever occurred sooner. Setting: The Leg Ulcer Clinics of Edinburgh and Falkirk and District Royal Infirmaries, Scotland. Patients: 132 patients with chronic leg ulcers and clinical evidence of chronic venous disease, and excluding those with Doppler ultrasound ankle/brachial pressure indices of less than 0.8, diabetes or rheumatoid disease. There were 28 withdrawals who were classified for analysis as treatment failures. Interventions: Elastic or non-elastic multilayer bandage systems were applied using similar application techniques by a team of trained nurse specialists. All other treatments were standardized, including the randomization of dressings to either a knitted viscose or a hydrocellular polyurethane dressing. Main outcome measure: Complete ulcer healing. Results: In the elastic group 35 out of 65 ulcers (54%) healed within 12 weeks compared with 19 out of 67 (28%) in the non-elastic group (95% confidence limits for percentage healed, 9% to 42%). Ulcer pain was also reported significantly less often in the elastic group (48% of visits versus 29%; p=0.03). Conclusion: When applied by similar multilayer bandaging techniques, elastic bandaging was significantly better than non-elastic bandaging in the treatment of chronic venous leg ulcer.