NCT02333123

Aspirin for Venous Ulcers: Randomised Trial (AVURT)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This efficacy study evaluates the safety and effectiveness of aspirin for venous leg ulcer healing. The study also examines whether patients can be recruited to a larger study. Patients with chronic venous leg ulceration presenting and undergoing care in leg ulcer community clinics or hospital out-patient clinics, or registered with a clinic but are receiving care at home will be recruited. All patients will receive standard compression bandaging. Half of the participants will be randomised to receive aspirin, while the other half will receive a placebo.

Detailed description

The mainstay of treatment of leg ulcers is graded compression therapy to squeeze the fluid out of the leg and venous system. This has been shown to be effective in many clinical trials. However, despite this treatment patients take many months to heal (with median healing times of approximately 12 weeks in previous trials) and for some patients compression therapy does not result in resolution of their leg ulcers. The use of compression (as well as dressings largely to manage the wound exudate) can be expensive as nurse time is required to change bandages which can be required weekly or more frequently. Furthermore, for many patients the compression therapy is uncomfortable (sometimes painful) and inconvenient for everyday life (compression is bulky and dressings have to be changed several times weekly). If other treatments were able to reduce the time to healing then this would be a significant breakthrough. Results from two earlier small trials suggest aspirin may be of benefit. However this trials were poorly designed and reported. The present study will evaluate whether the addition of 300mg of daily aspirin to standard evidence based therapies reduces the time to healing of chronic venous leg ulceration using a more rigorous design. The study will also establish the feasibility of satisfactory participant recruitment for a bigger trial, and whether participants are compliant with their aspirin therapy. The safety of aspirin in this patient population will also be monitored.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DRUG	Aspirin	Each 300mg aspirin capsule will contain over-encapsulated 4 x Aspirin 75mg tablets.
DRUG	Placebo (for Aspirin)	Each placebo capsule will contain a lactose and magnesium stearate blend, and will appear identical in weight, colour and size to the matched aspirin capsules.

Timeline

• Start date: 2015-07-10
• Primary completion: 2016-08-18
• Completion: 2016-11-11
• First posted: 2015-01-07
• Last updated: 2017-06-27

Locations

5 sites across 1 country: United Kingdom