None listed
Conditions
Brief summary
We propose a randomised double-blind multicentre placebo-controlled clinical trial to determine the clinical effectiveness of aspirin in addition to compression in healing venous leg ulcers. All eligible patients who are treated in participating wound clinics and who fulfil selection criteria will be offered study participation. All participants will be treated with best practice compression therapy. In addition to compression the Aspirin Group: will receive 300 mg of aspirin daily (one tablet each morning) and the Placebo Group: will receive placebo (one tablet in the morning). We will assess wound size/depth, serum samples for inflammatory markers, pain, score, compression adherence, medication adherence, Quality of Life scores, target ulcer recurrence, adverse events and blinding success
Interventions
Acetylsalicylic acid (ASA) 300 mg: enteric coated un-scored white tablet [ASPIRIN] taken once daily for 24 weeks.
All participants will be treated with compression therapy. The compression system utilised will be selected based on the treating Investigator's clinical judgement for each patient. Participants will be asked not to remove compression between treatments. Compression adherence will be checked from baseline and weekly until healed or to 12 weeks, whichever comes first, and once heal
Acetylsalicylic acid (ASA) 300 mg: enteric coated un-scored white tablet [ASPIRIN] taken once daily for 24 weeks. All participants will be treated with compression therapy. The compression system utilised will be selected based on the treating Investigator's clinical judgement for each patient. Participants will be asked not to remove compression between treatments. Compression adherence will be checked from baseline and weekly until healed or to 12 weeks, whichever comes first, and once healed 4-weekly to 24 weeks. Participants will be asked to self-report trial medication adherence, and to present medication containers for a pill-count at 24 weeks. As this is a study primarily evaluating the impact of aspirin therapy, the exact mode of compression therapy is secondary and indeed no particular compression system has been proven as universally superior. Adherence to medication will be checked throughout the study by participant self-report and by medication container return for pill-count at the end of the study period of 24 weeks.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants will include males and females, aged 18 years and older and have one or more leg ulcers in the presence of venous insufficiency confirmed by clinical assessment and/or duplex ultrasound. The ulcer must have been present for at least six weeks. Participants must have an Ankle Brachial Pressure Index [ABPI] measure of greater than or equal to 0.7 mmHg to exclude significant arterial insufficiency. The eligible target ulcer will have an area of greater than or equal to 1 cm2 to less than or equal to 20 cm2 as measured by digital planimetry techniques (largest ulcer on limb and separated from other ulcers by at least 1 cm). Participants must have been off aspirin for 6 weeks before coming into the study
Exclusion criteria
* 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
Outcome results
None listed