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

@entity1 @entity1066 @entity117 @entity3179
AIM: The aim of this study was to determine the effect of low-dose @entity117 on venous leg @entity1066 when used in addition to compression. BACKGROUND: The mainstay of treatment for @entity3179 is compression therapy and there are few adjuvant treatments to accelerate healing. DESIGN: Pragmatic, community-based, double-blind, randomized trial. METHODS: @entity1 with @entity3179 will receive either 150  mg @entity117 or placebo daily for up to 24  weeks. @entity1 will receive background treatment with compression therapy (system of choice guided by @entity1 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 @entity1066 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 @entity1 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.
