Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial

Area of Science:

• Vascular Medicine
• Dermatology
• Pharmacology

Background:

• Venous leg ulcers (VLUs) are a common and costly condition, affecting 1% of adults.
• Current treatments, primarily compression bandaging, are often prolonged, with up to 25% of VLUs failing to heal.
• Previous small trials suggest low-dose aspirin may aid VLU healing, but evidence is limited.

Purpose of the Study:

• To evaluate the efficacy of daily low-dose aspirin (300 mg) as an adjunct to standard care for chronic VLUs.
• To assess the feasibility and safety of aspirin treatment in patients with VLUs.
• To inform the design of a potential larger phase III study.

Main Methods:

• A phase II, randomized, double-blind, placebo-controlled trial (AVURT) involving 100 participants.
• Participants received either 300 mg aspirin or placebo daily, alongside standard compression therapy.
• Primary outcome: time to healing of the reference ulcer; secondary outcomes: ulcer size, pain, compliance, and adverse events.

Main Results:

• The primary analysis will compare time to healing between the aspirin and placebo groups using a Cox proportional hazards model.
• Secondary outcomes will provide data on ulcer healing rates, patient-reported pain, and safety profiles.
• Follow-up duration is a maximum of 27 weeks.

Conclusions:

• The AVURT trial aims to provide crucial data on aspirin's efficacy and safety for VLU treatment.
• Findings will determine if aspirin is a viable adjunctive therapy for VLUs.
• This study addresses a significant gap in the evidence for aspirin in VLU management.