Aspirin for Venous Ulcers: Randomised Trial (AVURT)

NCT02333123 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-06-27

No results posted yet for this study

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.

Conditions

  • Venous Leg Ulcer

Interventions

DRUG

Aspirin

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

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.

Sponsors & Collaborators

  • University of York

    collaborator OTHER
  • University of Manchester

    collaborator OTHER
  • Bradford Teaching Hospitals NHS Foundation Trust

    collaborator OTHER_GOV
  • Harrogate & District NHS Foundation Trust

    collaborator OTHER
  • Hull University Teaching Hospitals NHS Trust

    collaborator OTHER_GOV
  • University of Nottingham

    collaborator OTHER
  • Cardiff University

    collaborator OTHER
  • University of Newcastle Upon-Tyne

    collaborator OTHER
  • St George's, University of London

    lead OTHER

Principal Investigators

  • Robert J Hinchliffe, MD, FRCS · St George's Healthcare NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-10
Primary Completion
2016-08-18
Completion
2016-11-11

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02333123 on ClinicalTrials.gov