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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
Sponsor:
Collaborators:
University of York
University of Manchester
Bradford Teaching Hospitals NHS Foundation Trust
Harrogate & District NHS Foundation Trust
Hull and East Yorkshire Hospitals NHS Trust
University of Nottingham
Cardiff University
University of Newcastle Upon-Tyne
Information provided by (Responsible Party):
St George's, University of London

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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Drug: Aspirin Drug: Placebo (for Aspirin) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
Aspirin 300mg capsule by mouth once a day for 24 weeks.
Drug: Aspirin
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.




Primary Outcome Measures :
  1. Time to healing of the reference ulcer (the largest eligible ulcer) [ Time Frame: 25 weeks ]

Secondary Outcome Measures :
  1. Ulcer size (area) measured in square cm [ Time Frame: 25 weeks ]
  2. Recurrence of reference ulcer [ Time Frame: 25 weeks ]
    Proportion of participants with a recurrence of reference ulcer. Time to recurrence.

  3. Ulcer related pain using the VAS Score [ Time Frame: 5 weeks ]
  4. 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.

  5. 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.

  6. Number of adverse events [ Time Frame: 27 weeks ]
    Number of participants with at least one event. Total number of events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
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
Freeman Hospital
Newcastle Upon Tyne, United Kingdom, NE3 3HD
Sponsors and Collaborators
St George's, University of London
University of York
University of Manchester
Bradford Teaching Hospitals NHS Foundation Trust
Harrogate & District NHS Foundation Trust
Hull and East Yorkshire Hospitals NHS Trust
University of Nottingham
Cardiff University
University of Newcastle Upon-Tyne
Investigators
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Principal Investigator: Robert J Hinchliffe, MD, FRCS St George's Healthcare NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT02333123     History of Changes
Other Study ID Numbers: 14.0096
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Aspirin
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics