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Aspirin for Venous Ulcers: Randomised Trial (AVURT) (AVURT)

Primary Purpose

Venous Leg Ulcer

Status

Terminated

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Aspirin

Placebo (for Aspirin)

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hull & East Yorkshire Hospital NHS Trust
St George's University Hospitals NHS Foundation Trust
Harrogate & district NHS Trust
Brighton General Hosp
Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aspirin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to healing of the reference ulcer (the largest eligible ulcer)

Secondary Outcome Measures

Ulcer size (area) measured in square cm

Recurrence of reference ulcer

Proportion of participants with a recurrence of reference ulcer. Time to recurrence.

Ulcer related pain using the VAS Score

Treatment concordance: number of participants completing the course of treatment

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

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

Number of participants with at least one event. Total number of events.

Full Information

NCT ID

NCT02333123

First Posted

November 5, 2014

Last Updated

June 26, 2017

Sponsor

St George's, University of London

Collaborators

University of York, University of Manchester, Bradford Teaching Hospitals NHS Foundation Trust, Harrogate & District NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, University of Nottingham, Cardiff University, University of Newcastle Upon-Tyne

1. Study Identification

Unique Protocol Identification Number

NCT02333123

Brief Title

Aspirin for Venous Ulcers: Randomised Trial (AVURT)

Acronym

AVURT

Official Title

Aspirin for Venous Ulcers: Randomised Trial (AVURT)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Recruitment halted following TSC meeting due to poor recruitment and study unlikely to complete. Funders withdrew continued support

Study Start Date

July 10, 2015 (Actual)

Primary Completion Date

August 18, 2016 (Actual)

Study Completion Date

November 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St George's, University of London

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aspirin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo (for Aspirin)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to healing of the reference ulcer (the largest eligible ulcer)

Time Frame

25 weeks

Secondary Outcome Measure Information:

Title

Ulcer size (area) measured in square cm

Time Frame

25 weeks

Title

Recurrence of reference ulcer

Description

Proportion of participants with a recurrence of reference ulcer. Time to recurrence.

Time Frame

25 weeks

Title

Ulcer related pain using the VAS Score

Time Frame

5 weeks

Title

Treatment concordance: number of participants completing the course of treatment

Description

Time Frame

24 weeks

Title

Resource use

Description

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.

Time Frame

27 weeks

Title

Number of adverse events

Description

Number of participants with at least one event. Total number of events.

Time Frame

27 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert J Hinchliffe, MD, FRCS

Organizational Affiliation

St George's Healthcare NHS Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hull & East Yorkshire Hospital NHS Trust

City

Cottingham

State/Province

Castle hill hosp

ZIP/Postal Code

HU16 5JP

Country

United Kingdom

Facility Name

St George's University Hospitals NHS Foundation Trust

City

Tooting

State/Province

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Harrogate & district NHS Trust

City

Harrogate

State/Province

N.Yorkshire

Country

United Kingdom

Facility Name

Brighton General Hosp

City

Brighton

State/Province

Sussex

ZIP/Postal Code

BN2 3EW

Country

United Kingdom

Facility Name

Freeman Hospital

City

Newcastle Upon Tyne

ZIP/Postal Code

NE3 3HD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31349862

Citation

Helen T, Liz C, Laura C, Illary S, Martin B, Hannah B, Ian C, Jo D, Chris F, Rachael F, Rhian G, Keith H, Alison L, Ellie L, Catriona MD, Christine M, Debbie R, Gerard S, David T, Peter V, Laurie W, Robert H. Aspirin versus placebo for the treatment of venous leg ulcers-a phase II, pilot, randomised trial (AVURT). Trials. 2019 Jul 26;20(1):459. doi: 10.1186/s13063-019-3480-7.

Results Reference

derived

PubMed Identifier

30325305

Citation

Tilbrook H, Clark L, Cook L, Bland M, Buckley H, Chetter I, Dumville J, Fenner C, Forsythe R, Gabe R, Harding K, Layton A, Lindsay E, McDaid C, Moffatt C, Rolfe D, Sbizzera I, Stansby G, Torgerson D, Vowden P, Williams L, Hinchliffe R. AVURT: aspirin versus placebo for the treatment of venous leg ulcers - a Phase II pilot randomised controlled trial. Health Technol Assess. 2018 Oct;22(55):1-138. doi: 10.3310/hta22550.

Results Reference

derived

PubMed Identifier

26554558

Citation

Tilbrook H, Forsythe RO, Rolfe D, Clark L, Bland M, Buckley H, Chetter I, Cook L, Dumville J, Gabe R, Harding K, Layton A, Lindsay E, McDaid C, Moffatt C, Phillips C, Stansby G, Vowden P, Williams L, Torgerson D, Hinchliffe RJ. Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial. Trials. 2015 Nov 10;16:513. doi: 10.1186/s13063-015-1039-9.

Results Reference

derived

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Aspirin for Venous Ulcers: Randomised Trial (AVURT)

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