Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial

Area of Science:

• Vascular Medicine
• Dermatology
• Pharmacology

Background:

• Venous leg ulceration is a prevalent and costly condition, often resistant to standard compression therapy.
• High rates of unhealed ulcers (up to 50% after 2 years) and frequent recurrence necessitate novel treatment strategies.
• Inflammation is a key factor in venous ulcers, suggesting anti-inflammatory agents like aspirin as a potential therapeutic target.

Purpose of the Study:

• To evaluate the efficacy of daily aspirin as an adjunct to compression therapy for venous leg ulcer healing.
• To assess aspirin's impact on ulcer recurrence, pain, quality of life, and safety in patients with venous leg ulcers.

Main Methods:

• A randomized, double-blinded, multicenter, placebo-controlled trial involving 268 participants with venous leg ulcers.
• Participants received either 300-mg oral aspirin or a placebo daily, alongside standard compression therapy for 24 weeks.
• Primary outcome: time to ulcer healing within 12 weeks; secondary outcomes included recurrence, pain, quality of life, and adverse events.

Main Results:

• The study aimed to determine if aspirin improves the primary outcome of time to healing within 12 weeks.
• Secondary outcomes assessed included ulcer recurrence rates, wound pain, patient quality of life, and safety profiles at 24 weeks.

Conclusions:

• The Aspirin in Venous Leg Ulcer (ASPiVLU) trial investigated the efficacy and safety of aspirin as an adjunctive treatment.
• Findings will inform clinical practice regarding aspirin's role in managing challenging venous leg ulcers and preventing recurrence.