ACTRN12614000293662.

Trial name or title	Clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers: a randomised double‐blinded placebo‐controlled trial [the ASPiVLU study]
Methods	Prospective, randomised, double blinded, 2 groups in parallel
Participants	268 male or female Inclusion: Age 18 years and older Have one or more leg ulcers in the presence of venous insufficiency confirmed by clinical assessment and/or duplex ultrasound The target ulcer (largest ulcer) must be separated from other ulcers by at least 1 cm. The target ulcer must have been present for at least six weeks or has prior history of venous ulceration The target ulcer has an area ≥1 cm2 to ≤ 20 cm2 as measured by digital planimetry techniques An Ankle Brachial Pressure Index [ABPI] measure of ≥ 0.7 mmHg or systolic toe pressure ≥ 50 mmHg to exclude significant arterial insufficiency. Participant is able to give informed consent Exclusion criteria: Unable to attend scheduled treatment visits and comply with follow‐up contact with study staff Aspirin intolerance contraindication to aspirin (according to medical practitioner’s clinical judgement) Current, regular aspirin use Concurrent use of any other antiplatelet or anticoagulation therapy Any existing condition or treatment that is a contraindication to use of aspirin or to participate in the trial (decision made according to medical practitioner’s clinical judgement) Pregnancy or breastfeeding
Interventions	Aspirin Arm: will receive oral dose 300 mg enteric coated aspirin daily for 24 weeks Placebo Arm: will receive oral dose of placebo tablet daily for 24 weeks All participants will be treated with compression
Outcomes	Primary measures: Time to healing Proof of healing (100% epithelialisation with no scab and no exudate) Secondary measures: Proportion of participants with healed venous leg ulcers Recurrence of target ulcer: After healing, participants will be followed up to assess target ulcer recurrence Wound pain score Health‐related quality of life and wellbeing index Adverse Events Adherence to compression treatment or secondary prevention compression hosiery once healed Adherence to medication Serum samples Hospitalisation
Starting date	March 2015
Contact information	carolina.weller@monash.edu maria.lachina@monash.edu
Notes	Financial support from the National Health and Medical Research Council of Australia (APP1069329). ASPiVLU is registered with Australian New Zealand Clinical Trials Registry. Registration number: ACTRN12614000293662 Bayer Schering Pharm manufactured the aspirin and matching placebo.