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Aspirin for venous ulcers: randomised trial (AVURT): study protocol for a randomised controlled trial

Tilbrook, Helen; Forsythe, Rachael O.; Rolfe, Debbie; Clark, Laura; Bland, Martin; Buckley, Hannah; Chetter, Ian; Cook, Liz; Dumville, Jo; Gabe, Rhian; Harding, Keith; Layton, Alison; Lindsay, Ellie; McDaid, Catriona; Moffatt, Christine; Phillips, Ceri; Stansby, Gerard; Vowden, Peter; Williams, Laurie; Torgerson, David; Hinchliffe, Robert J.

Authors

Helen Tilbrook

Rachael O. Forsythe

Debbie Rolfe

Laura Clark

Martin Bland

Hannah Buckley

Ian Chetter

Liz Cook

Jo Dumville

Rhian Gabe

Keith Harding

Alison Layton

Ellie Lindsay

Catriona McDaid

Christine Moffatt

Ceri Phillips

Gerard Stansby

Peter Vowden

Laurie Williams

David Torgerson

Robert J. Hinchliffe



Abstract

Background: Venous leg ulcers (VLUs) are the commonest cause of leg ulceration, affecting 1 in 100 adults. There is a significant health burden associated with VLUs – it is estimated that the cost of treatment for 1 ulcer is up to £1300 per year in the NHS. The mainstay of treatment is with graduated compression bandaging; however, treatment is often prolonged and up to one quarter of venous leg ulcers do not heal despite standard care. Two previous trials have suggested that low-dose aspirin, as an adjunct to standard care, may hasten healing, but these trials were small and of poor quality. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established.

Methods/Design: AVURT is a phase II randomised double blind, parallel-group, placebo-controlled efficacy trial. The primary objective is to examine whether aspirin, in addition to standard care, is effective in patients with chronic VLUs (i.e. over 6 weeks in duration or a history of VLU). Secondary objectives include feasibility and safety of aspirin in this population. A target of 100 participants, identified from community leg ulcer clinics and hospital clinics, will be randomised to receive either 300 mg of aspirin once daily or placebo. All participants will receive standard care with compression therapy. The primary outcome will be time to healing of the reference ulcer. Follow-up will occur for a maximum of 27 weeks. The primary analysis will use a Cox proportional hazards model to compare time to healing using the principles of intention-to-treat. Secondary outcomes will include ulcer size, pain evaluation, compliance and adverse events.

Discussion: The AVURT trial will investigate the efficacy and safety of aspirin as a treatment for VLU and will inform on the feasibility of proceeding to a larger phase III study. This study will address the paucity of information currently available regarding aspirin therapy to treat VLU.

Journal Article Type Article
Publication Date Nov 10, 2015
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 16
Article Number 513
APA6 Citation Tilbrook, H., Forsythe, R. O., Rolfe, D., Clark, L., Bland, M., Buckley, H., …Hinchliffe, R. J. (2015). Aspirin for venous ulcers: randomised trial (AVURT): study protocol for a randomised controlled trial. Trials, 16, https://doi.org/10.1186/s13063-015-1039-9
DOI https://doi.org/10.1186/s13063-015-1039-9
Keywords Leg ulcer, Venous ulcer, Wound healing, Aspirin, Compression therapy
Publisher URL http://dx.doi.org/10.1186/s13063-015-1039-9
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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