Clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers: a randomised double-blind placebo-controlled trial [the ASPiVLU study]

Phase 3

Completed

• Conditions: Venous Leg Ulcer; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Skin - Other skin conditions

• Registration Number: ACTRN12614000293662
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-20
• Study Completion: 2018-11-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to determine whether aspirin as an adjunct to compression improves time to healing of venous leg ulcers[Time to healing will be measured by assessing the size of the ulcer that will be measured at baseline and fortnightly until healed using digital planimetry. Proof of healing: will be measured by independent expert review of digital photos of the ulcer at baseline and fortnightly until healed or to 12 weeks, whichever comes first. The ulcer will be photographed using a digital camera to allow independent verification of ulcer size and proof of healing (100% epithelialisation). A paper ruler with mm/cm markings will be used in each photo next to the ulcer to verify size.]

Secondary Outcome Measures

Name	Time	Method
The rate of ulcer recurrence over 6 months[Participants with healed VLU will be phoned to assess target ulcer recurrence and by research nurse at monthly intervals to check if the healed target VLU has recurred (if recurrence noted the participant will be referred to wound clinic). Monthly phone calls will continue for up to 6 months following randomisation and will commence at the 12-week from baseline visit]