Low Dose Aspirin for Venous Leg Ulcers

• Status: Completed
• Trial end date: 2017-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work, lifestyles and activity, especially in older patients. There are few effective treatments - compression therapy (tight bandaging or stockings) helps healing, but about half the people with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking aspirin as well as using compression may speed up healing for VLU, but the current evidence is not enough to change clinical practice. We will conduct a randomised controlled trial to test whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Auckland, New Zealand
• Collaborator: Health Research Council, New Zealand
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Aged 18 years or older

• Determined to have a venous leg ulcer (clinical indications of venous ulceration, Ankle Brachial Index ≥ 0.8, and other causative aetiologies ruled out)

• Able to tolerate compression therapy

• Able to provide written informed consent

• Confirmation with participant's general practitioner that the participant can take low dose aspirin or placebo.

Exclusion Criteria:

• Pregnant or breast-feeding women

• History of myocardial infarction, stroke, transient ischaemic attack, angina or significant peripheral arterial disease

• History of adverse effects related to aspirin use

• Currently using aspirin, or other anti-platelet or anticoagulant therapy

• Opinion of screening medical practitioner at National Institute of Health Innovation that participant has an existing condition or treatment that is a contraindication to use of aspirin or to participation in the trial.