What is ASPiVLU?
ASPiVLU is a study looking at the role of aspirin in the treatment of venous leg ulcers. The study will determine whether daily treatment of aspirin as an adjunct to compression bandaging will decrease time to healing of venous leg ulcers aswell as examine whether aspirin decreases the risk of ulcer recurrence after healing. ASPiVLU is a randomised double-blind multicentre placebo-controlled clinical trial which involves people aged 18 years or older.
Participants are randomly assigned (or randomised) to take either an aspirin tablet (300mg) or a matching placebo tablet (dummy pill) for 24 weeks. All participants receive compression therapy as delivered through wound clinics, GP clinics and community nursing services. The study aims to enrol 268 patients over 2 years at locations in Queensland, New South Wales, Victoria and Tasmania.
ASPiVLU is funded by the National Health and Medical Research Council (APP1069329) with support from Bayer Pharma AG and Pharm Pack Pro. ASPiVLU is registered with Australian New Zealand Clinical Trials Registry. Registration number: ACTRN12614000293662
The outcome of the trial
The findings may improve the quality of life and reduce treatment costs for a large number of people in the future. If proved effective the low cost of aspirin therapy would make it an affordable therapeutic agent for people with VLUs worldwide.
The aim of the ASPirin in Venous Leg Ulcer (ASPiVLU) study is to assess whether daily treatment with 300mg aspirin in addition to compression therapy can improve time to healing and reduce incidence of ulcer recurrence.
Inclusion and Exclusion Criteria
The following inclusion and exclusion criteria will be applied to determine eligible patients at the wound clinics:
- Males and females
- 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
- Unable to attend scheduled treatment visits and comply with follow-up contact with study staff
- Current, regular aspirin use
- Aspirin intolerance
- Any existing condition or treatment that is a contraindication to aspirin or to participate in the trial (decision made according to medical practitioner’s clinical judgement)
- Concurrent use of any other antiplatelet or anticoagulation therapy
- Pregnancy or breastfeeding