Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial.

Carolina D Weller,Michael Woodward,Paula Loveland,Sankar Sinha,Terrence Haines,Anna Barker,Ian Darby,Pat Aldons,Martin Underwood,Rory Wolfe,Mauro Vicaretti,Stephanie Ward,Elizabeth Dapiran,Jason J Madan,John Mcneil

doi:10.1186/s13063-016-1314-4

Abstract

BackgroundVenous leg ulceration is a common and costly problem that is expected to worsen as the population ages. Current treatment is compression therapy; however, up to 50 % of ulcers remain unhealed after 2 years, and ulcer recurrence is common. New treatments are needed to address those wounds that are more challenging to heal. Targeting the inflammatory processes present in venous ulcers is a possible strategy. Limited evidence suggests that a daily dose of aspirin may be an effective adjunct to aid ulcer healing and reduce recurrence. The Aspirin in Venous Leg Ulcer study (ASPiVLU) will investigate whether 300-mg oral doses of aspirin improve time to healing.Methods/designThis randomised, double-blinded, multicentre, placebo-controlled, clinical trial will recruit participants with venous leg ulcers from community settings and hospital outpatient wound clinics across Australia. Two hundred sixty-eight participants with venous leg ulcers will be randomised to receive either aspirin or placebo, in addition to compression therapy, for 24 weeks. The primary outcome is time to healing within 12 weeks. Secondary outcomes are ulcer recurrence, wound pain, quality of life and wellbeing, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks.DiscussionThe ASPiVLU trial will investigate the efficacy and safety of aspirin as an adjunct to compression therapy to treat venous leg ulcers. Study completion is anticipated to occur in December 2018.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12614000293662

Highlights

Venous leg ulceration is a common and costly problem that is expected to worsen as the population ages
Up to 70 % of venous leg ulcer (VLU) will heal within 12 weeks if adequate compression is applied and patients adhere to compression treatment [6]
An RCT conducted in the United Kingdom [21] (n = 20) reported that daily oral administration of aspirin (300 mg) with compression decreased the time to ulcer healing (p < 0.01) and the proportion of participants healed when compared to placebo with compression bandaging over a 4-month period

Summary

Discussion

This protocol outlines the design of a randomised, double-blinded, multicentre, placebo-controlled, clinical trial of aspirin in the management of VLUs. Authors’ contributions CW is the lead investigator, conceived the study, designed the trial, obtained funding, drafted the original manuscript, and co-ordinated the protocol development and writing process. TH contributed to the development and design of the ASPiVLU study and provided critical revisions to the manuscript for intellectual content. PA is a clinician researcher involved in recruitment and the acquisition of data from a clinical site in Queensland. SS is a clinician researcher involved in recruitment and the acquisition of data from a clinical site in Tasmania.

Background

Methods/design

Findings