Abstract:
Study question What is the added effect of daily low dose aspirin on ulcer healing when used in conjunction with compression therapy in patients with venous leg ulcers? Methods 251 participants with venous leg ulcers managed by community nursing services were randomised to take 150 mg oral aspirin daily (n=125) or matching placebo (n=126) in addition to compression therapy. The primary outcome was time to complete healing of the reference ulcer (largest ulcer if more than one). Secondary outcomes were percentage of participants healed at endpoint (at or about 24 weeks), estimated change from baseline in ulcer area, change in health related quality of life, treatment adherence, incidence of adverse events, and efficacy of blinding. Study answer and limitations Median time to healing was 77 days in the aspirin group and 69 days in the placebo group (hazard ratio 0.85, 95% confidence interval 0.64 to 1.13). At endpoint 70% (n=88) of participants had healed in the aspirin group and 80% (n=101) in the placebo group (risk difference 9.8%, 95% confidence interval 20.4% to 0.9%). Changes from baseline for both estimated ulcer area and health related quality of life did not differ between groups. Treatment adherence was about 73%. 40 adverse events occurred in the aspirin group and 37 in the placebo group (incidence rate ratio 1.1, 95% confidence interval 0.7 to 1.7). Blinding was effective. The main limitation of the study was that data were only collected on healing of the reference ulcer. What this study adds Low dose aspirin does not increase the healing of venous leg ulcers. For people with venous leg ulcers taking aspirin for other indications, a low dose may slow healing, but seven out of every 10 people will heal within 24 weeks if being treated with compression therapy. Funding, competing interests, data sharing Aspirin4VLU was funded by the Health Research Council of New Zealand. The authors have no competing interests. Requests for deidentified data or study documents are welcomed. Trial registration ClinicalTrials.gov NCT02158806.
