NCT02333123

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

July 10, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2016

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

November 5, 2014

Last Update Submit

June 26, 2017

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

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

    25 weeks

Secondary Outcomes (6)

  • Ulcer size (area) measured in square cm

    25 weeks

  • Recurrence of reference ulcer

    25 weeks

  • Ulcer related pain using the VAS Score

    5 weeks

  • Treatment concordance: number of participants completing the course of treatment

    24 weeks

  • Resource use

    27 weeks

  • +1 more secondary outcomes

Study Arms (2)

Aspirin

EXPERIMENTAL

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

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (for Aspirin)

Interventions

AspirinDRUG

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

Aspirin
Placebo (for Aspirin)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.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hull & East Yorkshire Hospital NHS Trust

Cottingham, Castle Hill Hosp, HU16 5JP, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

Tooting, London, SW17 0QT, United Kingdom

Location

Harrogate & district NHS Trust

Harrogate, N.Yorkshire, United Kingdom

Location

Brighton General Hosp

Brighton, Sussex, BN2 3EW, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE3 3HD, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 31349862DERIVED

  • 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.

    PMID: 30325305DERIVED

  • 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.

    PMID: 26554558DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Robert J Hinchliffe, MD, FRCS

    St George's Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

January 7, 2015

Study Start

July 10, 2015

Primary Completion

August 18, 2016

Study Completion

November 11, 2016

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

GB(5)