NCT02158806.

Trial name or title	Low dose aspirin for venous leg ulcers (Aspirin4VLU)
Methods	Prospective, randomised, double blinded, 2 groups in parallel
Participants	Estimated enrolment: 354 patients; 18 years or older; both genders Inclusion criteria: Diagnosed with venous leg ulcers (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
Interventions	Experimental: aspirin 150 mg capsule once daily for up to 24 weeks Placebo comparator: inert capsule matching aspirin capsule once daily for up to 24 weeks
Outcomes	Primary outcome measures Time to complete healing of reference ulcer (time frame: 24 weeks; designated as safety issue: no) Time to event (complete healing defined as intact skin with absence of scab) Secondary outcome measures Proportion of participants with healed venous leg ulcers (time frame: 24 weeks; designated as safety issue: no) Proportion of participants in each arm with completely healed reference ulcers at 24 weeks Change in health‐related quality of life (generic) (time frame: 24 weeks; designated as safety issue: no) Change in generic health‐related quality of life (measured by Short Form 36) from baseline to 24 weeks Adverse events (time frame: 24 weeks; designated as safety issue: yes) Incidence rate ratio of adverse events and serious adverse events at 24 weeks Adherence to treatment (time frame: 24 weeks; designated as safety issue: no) Adherence to study medication as measured by pill counts at 24 weeks Change in health‐related quality of life (disease‐specific) (time frame: 24 weeks; designated as safety issue: no) Change in disease‐specific health‐related quality of life (measured by Charing Cross Venous Ulcer Questionnaire) from baseline to 24 weeks
Starting date	January 2015
Contact information	Andrew Jull a.jull@auckland.ac.nz; Chris Bullen c.bullen@auckland.ac.nz
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