AVURT is a Phase II trial which compares aspirin to placebo for the treatment of venous leg ulcers.
The study is led by Mr Robert Hinchliffe at St George’s University of London and is coordinated by Helen Tilbrook at the University of York’s Trials Unit.
The trial closed on 14 December 2016.
Venous leg ulcers are wounds of the lower limb caused by a diseased venous system which result in chronically swollen legs and damage to the tissues around the ankles. They are most commonly the result of severe varicose veins, a previous deep vein thrombosis or failure of the calf muscle pump.
Patients are usually treated with compression therapy to squeeze the fluid out of the leg and venous system. This has been shown to be effective in many clinical trials (O’Meara, 2012). However, despite this treatment patients may take many months to heal and some patients do not. Compression and the use of dressings can be expensive as nurses are required to change the bandages frequently. Also, some patients find the compression therapy uncomfortable, sometimes painful and inconvenient for everyday life.
Two small trials (Layton 1994, del Río Solá, 2012) have suggested that high dose (300mg) aspirin, in addition to compression therapy, might improve the healing of venous leg ulcers.
In this small trial we want to test whether aspirin is better than placebo at improving the healing of venous leg ulcers, and if aspirin is safe to use in people with venous leg ulcers. We wish to include 100 patients in the study.
If our study shows that taking aspirin could be beneficial, we hope to conduct a larger study with more patients.
Researchers at the University of York Trials Unit will analyse the information collected.
The trial protocol has now been published.