Aspirin for Venous Ulcers: Randomised Trial (AVURT) (AVURT)
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|ClinicalTrials.gov Identifier: NCT02333123|
Recruitment Status : Terminated (Recruitment halted following TSC meeting due to poor recruitment and study unlikely to complete. Funders withdrew continued support)
First Posted : January 7, 2015
Last Update Posted : June 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Venous Leg Ulcer||Drug: Aspirin Drug: Placebo (for Aspirin)||Phase 2|
The mainstay of treatment of leg ulcers is graded compression therapy to squeeze the fluid out of the leg and venous system. This has been shown to be effective in many clinical trials. However, despite this treatment patients take many months to heal (with median healing times of approximately 12 weeks in previous trials) and for some patients compression therapy does not result in resolution of their leg ulcers. The use of compression (as well as dressings largely to manage the wound exudate) can be expensive as nurse time is required to change bandages which can be required weekly or more frequently. Furthermore, for many patients the compression therapy is uncomfortable (sometimes painful) and inconvenient for everyday life (compression is bulky and dressings have to be changed several times weekly). If other treatments were able to reduce the time to healing then this would be a significant breakthrough.
Results from two earlier small trials suggest aspirin may be of benefit. However this trials were poorly designed and reported. The present study will evaluate whether the addition of 300mg of daily aspirin to standard evidence based therapies reduces the time to healing of chronic venous leg ulceration using a more rigorous design. The study will also establish the feasibility of satisfactory participant recruitment for a bigger trial, and whether participants are compliant with their aspirin therapy. The safety of aspirin in this patient population will also be monitored.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Aspirin for Venous Ulcers: Randomised Trial (AVURT)|
|Actual Study Start Date :||July 10, 2015|
|Actual Primary Completion Date :||August 18, 2016|
|Actual Study Completion Date :||November 11, 2016|
Aspirin 300mg capsule by mouth once a day for 24 weeks.
Each 300mg aspirin capsule will contain over-encapsulated 4 x Aspirin 75mg tablets.
Placebo Comparator: Placebo
Placebo capsule (for aspirin 300mg capsule) by mouth once a day for 24 weeks.
Drug: Placebo (for Aspirin)
Each placebo capsule will contain a lactose and magnesium stearate blend, and will appear identical in weight, colour and size to the matched aspirin capsules.
- Time to healing of the reference ulcer (the largest eligible ulcer) [ Time Frame: 25 weeks ]
- Ulcer size (area) measured in square cm [ Time Frame: 25 weeks ]
- Recurrence of reference ulcer [ Time Frame: 25 weeks ]Proportion of participants with a recurrence of reference ulcer. Time to recurrence.
- Ulcer related pain using the VAS Score [ Time Frame: 5 weeks ]
- Treatment concordance: number of participants completing the course of treatment [ Time Frame: 24 weeks ]Proportion of participants completing the course of treatment up to healing or planned trial exit. The number of capsules taken. Nurse's assessment of participant's compliance with recommended compression therapy.
- Resource use [ Time Frame: 27 weeks ]Number and duration of all leg ulcer-related appointments with health professionals (including wound related in-patient stays ). Number of and types of dressings used.
- Number of adverse events [ Time Frame: 27 weeks ]Number of participants with at least one event. Total number of events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333123
|Hull & East Yorkshire Hospital NHS Trust|
|Cottingham, Castle hill hosp, United Kingdom, HU16 5JP|
|St George's University Hospitals NHS Foundation Trust|
|Tooting, London, United Kingdom, SW17 0QT|
|Harrogate & district NHS Trust|
|Harrogate, N.Yorkshire, United Kingdom|
|Brighton General Hosp|
|Brighton, Sussex, United Kingdom, BN2 3EW|
|Newcastle Upon Tyne, United Kingdom, NE3 3HD|
|Principal Investigator:||Robert J Hinchliffe, MD, FRCS||St George's Healthcare NHS Trust|