Aspirin for Venous Ulcers: Randomised Trial (AVURT)

• Status: Terminated
• Trial end date: 2016-11-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St George's, University of London
• Collaborators: Bradford Teaching Hospitals NHS Foundation Trust; Cardiff University; Harrogate & District NHS Foundation Trust; Hull and East Yorkshire Hospitals NHS Trust; Hull University Teaching Hospitals NHS Trust; University of Manchester; University of Newcastle Upon-Tyne; University of Nottingham; University of York
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Those with at least one chronic venous leg ulcer - where chronic venous leg ulceration is defined as any break in the skin which has either: a) been present for more than six weeks, or b) occurred in a person with a history of venous leg ulceration. Ulcers will be considered purely venous if clinically no other etiology was suspected. For this the ulcer must be venous in appearance (i.e. moist, shallow, of an irregular shape) and lie wholly or partially within the gaiter region of the leg. If the patient has more than one ulcer we will choose the largest ulcer as the 'index' lesion for purposes of the analysis.

• Ulcer area > 1 square cm

• Participants must have had an ankle brachial pressure index (ABPI) ≥ 0.8 taken within the previous three months. When the ABPI is incompressible other forms of assessment including peripheral pulse examination / toe pressure / duplex ultrasound in combination with clinical judgement to be used to exclude PAD

• Aged ≥ 18 years (no upper age limit)

• Able and willing to provide informed consent

• Ulcer duration > 6 weeks or prior history of venous ulceration.

Exclusion Criteria:

• Unable to provide consent

• Unwilling to provide consent

• Foot (below the ankle) ulcer

• A leg ulcer of non-venous aetiology (i.e. arterial)

• Ankle-brachial pressure index (ABPI) <0.8

• Current regular use of aspirin (as may be randomised to placebo)

• Previous intolerance of aspirin / contraindication to aspirin (decision made according to the prescribers' clinical judgement)

• Prohibited medication: Probenecid

• Known lactose intolerance (as placebo contains lactose)

• Pregnant/lactating women

• Currently participating in another study evaluating leg ulcer therapies.

• Another reason that excluded them from participating within this trial (decision made according to the nurses' or prescribers' clinical judgment )*

• Previously been recruited in to this trial.