Aspirin for Venous Ulcers: Randomised Trial (AVURT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-10

Study Completion Date

2016-11-11

Brief Summary

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This efficacy study evaluates the safety and effectiveness of aspirin for venous leg ulcer healing. The study also examines whether patients can be recruited to a larger study. Patients with chronic venous leg ulceration presenting and undergoing care in leg ulcer community clinics or hospital out-patient clinics, or registered with a clinic but are receiving care at home will be recruited. All patients will receive standard compression bandaging. Half of the participants will be randomised to receive aspirin, while the other half will receive a placebo.

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Detailed Description

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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.

Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aspirin

Aspirin 300mg capsule by mouth once a day for 24 weeks.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Each 300mg aspirin capsule will contain over-encapsulated 4 x Aspirin 75mg tablets.

Placebo

Placebo capsule (for aspirin 300mg capsule) by mouth once a day for 24 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (for Aspirin)

Intervention Type DRUG

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.

Interventions

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Aspirin

Each 300mg aspirin capsule will contain over-encapsulated 4 x Aspirin 75mg tablets.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Those with at least one chronic venous leg ulcer - where chronic venous leg ulceration is defined as any break in the skin which has either: a) been present for more than six weeks, or b) occurred in a person with a history of venous leg ulceration. Ulcers will be considered purely venous if clinically no other etiology was suspected. For this the ulcer must be venous in appearance (i.e. moist, shallow, of an irregular shape) and lie wholly or partially within the gaiter region of the leg. If the patient has more than one ulcer we will choose the largest ulcer as the 'index' lesion for purposes of the analysis.
* Ulcer area \> 1 square cm
* Participants must have had an ankle brachial pressure index (ABPI) ≥ 0.8 taken within the previous three months. When the ABPI is incompressible other forms of assessment including peripheral pulse examination / toe pressure / duplex ultrasound in combination with clinical judgement to be used to exclude PAD
* Aged ≥ 18 years (no upper age limit)
* Able and willing to provide informed consent
* Ulcer duration \> 6 weeks or prior history of venous ulceration.

Exclusion Criteria

* Unable to provide consent
* Unwilling to provide consent
* Foot (below the ankle) ulcer
* A leg ulcer of non-venous aetiology (i.e. arterial)
* Ankle-brachial pressure index (ABPI) \<0.8
* Current regular use of aspirin (as may be randomised to placebo)
* Previous intolerance of aspirin / contraindication to aspirin (decision made according to the prescribers' clinical judgement)
* Prohibited medication: Probenecid
* Known lactose intolerance (as placebo contains lactose)
* Pregnant/lactating women
* Currently participating in another study evaluating leg ulcer therapies.
* Another reason that excluded them from participating within this trial (decision made according to the nurses' or prescribers' clinical judgment )\*
* Previously been recruited in to this trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No