Low-dose aspirin as an adjuvant treatment for venous leg ulceration: study protocol for a randomized controlled trial (Aspirin4 VLU).

Aim The aim of this study was to determine the effect of low-dose aspirin on venous leg ulcer healing when used in addition to compression. Background The mainstay of treatment for venous leg ulcers is compression therapy and there are few adjuvant treatments to accelerate healing. Design Pragmatic, community-based, double-blind, randomized trial. Methods Participants with venous leg ulcers will receive either 150 mg aspirin or placebo daily for up to 24 weeks. 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 24 weeks, 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. Discussion The 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 registration Registered 5 June 2014 ClinicalTrials.gov NCT02158806. Protocol version 1·1, 14 April 2015. [ABSTRACT FROM AUTHOR]