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Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial
Helen Tilbrook1, Rachael O Forsythe2, Debbie Rolfe3
1Department of Health Sciences, York Trials Unit, University of York, York, UK. helen.tilbrook@york.ac.uk.
Insights
This study investigated if low-dose aspirin speeds healing for venous leg ulcers (VLUs). Results will guide larger trials on aspirin
Area of Science:
- Vascular Medicine
- Dermatology
- Pharmacology
Background:
- Venous leg ulcers (VLUs) are a common and costly condition, affecting 1% of adults.
- Current treatments, primarily compression bandaging, are often prolonged, with up to 25% of VLUs failing to heal.
- Previous small trials suggest low-dose aspirin may aid VLU healing, but evidence is limited.
Purpose of the Study:
- To evaluate the efficacy of daily low-dose aspirin (300 mg) as an adjunct to standard care for chronic VLUs.
- To assess the feasibility and safety of aspirin treatment in patients with VLUs.
- To inform the design of a potential larger phase III study.
Main Methods:
- A phase II, randomized, double-blind, placebo-controlled trial (AVURT) involving 100 participants.
- Participants received either 300 mg aspirin or placebo daily, alongside standard compression therapy.
- Primary outcome: time to healing of the reference ulcer; secondary outcomes: ulcer size, pain, compliance, and adverse events.
Main Results:
- The primary analysis will compare time to healing between the aspirin and placebo groups using a Cox proportional hazards model.
- Secondary outcomes will provide data on ulcer healing rates, patient-reported pain, and safety profiles.
- Follow-up duration is a maximum of 27 weeks.
Conclusions:
- The AVURT trial aims to provide crucial data on aspirin's efficacy and safety for VLU treatment.
- Findings will determine if aspirin is a viable adjunctive therapy for VLUs.
- This study addresses a significant gap in the evidence for aspirin in VLU management.
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.
Trial Registration:
The study is registered on a public database with clinicaltrials.gov ( NCT02333123 ; registered on 5 November 2014).
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