Failure of a trial evaluating the effect of venous surgery on healing and recurrence rates in venous ulcers? The USABLE trial: rationale, design and methodology, and reasons for failure

Abstract

Objective: This Medical Research Council funded trial was set up to investigate whether venous surgery provided any additional benefit in the healing and recurrence rates of venous ulcers over compression bandaging alone. Methods: Ulcer surgery as adjuvant to compression bandaging for leg ulcers (USABLE) was a multicentre, randomized controlled trial, which planned to recruit 1000 venous ulcer patients to receive either compression bandaging alone or compression bandaging plus venous surgery. Follow up recorded ulcer healing, recurrence and patient quality of life. Results: Recruitment was slow, and involved screening a large number of patients (759) with only 75 randomized over an 18-month recruitment period. Conclusions: The results would infer that surgery is unlikely to be a management option for the majority of patients presenting to a hospital with a gaiter area leg ulcer.