Low-dose aspirin as an adjuvant treatment for venous leg ulceration: study protocol for a randomized controlled trial (Aspirin4VLU)

AimThe aim of this study was to determine the effect of low-dose aspirin on venous leg ulcer healing when used in addition to compression. BackgroundThe mainstay of treatment for venous leg ulcers is compression therapy and there are few adjuvant treatments to accelerate healing. DesignPragmatic, community-based, double-blind, randomized trial. MethodsParticipants with venous leg ulcers will receive either 150mg aspirin or placebo daily for up to 24weeks. Participants will receive background treatment with compression therapy (system of choice guided by participant and/or clinical preference) delivered through district nursing services. The primary outcome will be time-to-healing. Secondary outcomes will include proportion healed at 24weeks, change in ulcer area, change in health-related quality of life, adherence, efficacy of blinding and adverse events. The trial was funded in June 2014. DiscussionThe trial commenced in March 2015 and is successfully recruiting. The trial is one of three trials that will contribute to an individual participant data meta-analysis to be undertaken at the York Trials Centre. Trial registrationRegistered 5 June 2014 ClinicalTrials.gov NCT02158806. Protocol version 11, 14 April 2015.