AVURT
Research type
Research Study
Full title
Phase II randomised double blind, parallel group, placebo-controlled trial comparing the effect of the addition of 300mg daily dose of Aspirin plus standard care on the healing time of venous leg ulcers: AVURT
IRAS ID
164965
Contact name
Robert Hinchliffe
Contact email
Sponsor organisation
St George's Hospital
Eudract number
2014-003979-39
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Compression therapy is the main treatment for venous leg ulcers but it can be uncomfortable, inconvenient for everyday life and take patients many months to heal. Aspirin is not prescribed for leg ulcers but is commonly prescribed for other conditions and is a cheap drug with relatively few side effects. Some small poorly conducted trials (Layton 1994, del Río Solá ML 2012) have indicated that high dose (300mg) daily aspirin might improve the healing of venous leg ulcers in addition to compression but further research is required.
This study is a small randomised controlled trial but with potential to extend in to a larger trial, which aims to test whether aspirin improves the healing time of venous leg ulcers, and if it is safe to use in people with leg ulcers. We will recruit patients from community and hospital leg ulcer clinics. If patients consent they will be fully assessed in the standard way in a leg ulcer clinic. All patients will receive standard compression bandaging. Half the patients will receive (at random) either Aspirin (300mg) or a dummy drug (placebo), which they should take daily for a maximum of 24 weeks or until the ulcer heals if earlier. The Aspirin and placebo will be identical in appearance, and patients and doctors will not know which each patient has received (although if there were potential side effects it would be possible to see which drug they are taking).
Patients will complete a pain score and a photograph to record wound size will be taken on a weekly basis (approx.). We will focus on time to healing of ulcers (and secondarily ulcer size) over 25 weeks post-randomisation as the main measure of treatment success. After 6 months, patients would have completed the trial whether they had healed or not.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1305
Date of REC Opinion
29 Jan 2015
REC opinion
Further Information Favourable Opinion