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Low Dose Aspirin for Venous Leg Ulcers (Aspirin4VLU)

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ClinicalTrials.gov Identifier: NCT02158806
Recruitment Status : Completed
First Posted : June 9, 2014
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Health Research Council, New Zealand
Information provided by (Responsible Party):
Andrew Jull, University of Auckland, New Zealand

Brief Summary:
Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work, lifestyles and activity, especially in older patients. There are few effective treatments - compression therapy (tight bandaging or stockings) helps healing, but about half the people with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking aspirin as well as using compression may speed up healing for VLU, but the current evidence is not enough to change clinical practice. We will conduct a randomised controlled trial to test whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Drug: Aspirin Drug: Placebo Phase 3

Detailed Description:

A pragmatic, community based, double-blind, placebo-controlled, randomised trial to determine whether low dose aspirin accelerates venous leg ulcer healing at 24 weeks when used in addition to compression. Participants in have compression therapy (system of choice guided by patient and/or clinical preference) as delivered through district nursing services at the study centres as a background treatment. Low dose aspirin (150 mg) or placebo will be taken once daily as an oral capsule.

Participants will be district nursing service patients in five study centres in New Zealand with prevalent or incident venous leg ulcers. A venous leg ulcer will be defined as a wound on the lower leg that has remained unhealed for 4 or more weeks, appears to be primarily venous in aetiology with other causative diseases ruled out. If the participant has two or more venous leg ulcers, the largest ulcer will be the reference ulcer.

Participants will receive three visits from the research nurse - visit 1 to screen for eligibility, visit 2 to consent and randomise the participant, visit 3 to collect outcome data. District nurses will continue to visit the participant (about weekly or more frequently if required) to provide routine care between research nurse visits.

Block randomisation will be used, stratified by study centre and prognostic index (ulcer size greater than 5cm2 and ulcer duration greater than 6 months) to ensure a balance of participants within study centres and for participants likely to be slow healers. Research nurses in the study centres will contact a central telephone answering service, provide information on inclusion criteria, exclusion criteria, and relevant clinical history on consented participants. Randomised participants will receive a bottle of 168 capsules of study medication identified only by unique code and will take the capsule until the reference ulcer heals or up to 24 weeks, whichever occurs sooner.

Participants will take the study medication for up to 24 weeks or until the reference ulcer heals. If the participant has a serious adverse event, needs to start taking aspirin, or must stop taking aspirin to use other medications, they will be withdrawn from treatment, although they will still be followed up at 24 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Identical placebo with only difference being unique code on bottle containing product.
Primary Purpose: Treatment
Official Title: Low Dose Aspirin for Venous Leg Ulcers: a Randomised Trial
Study Start Date : March 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
150 mg capsule once daily for up to 24 weeks
Drug: Aspirin
150 mg aspirin in capsule form once daily for up to 24 weeks

Placebo Comparator: Inert capsule
Matching capsule once daily for up to 24 weeks
Drug: Placebo
Matching placebo capsule containing inert bulking agent




Primary Outcome Measures :
  1. Time to Complete Healing of Reference Ulcer [ Time Frame: 24 weeks ]
    Time to event (complete healing defined as intact skin with absence of scab)


Secondary Outcome Measures :
  1. Number of Participants With Healed Venous Leg Ulcers [ Time Frame: 24 weeks ]
    Number of participants in each arm with completely healed reference ulcers at 24 weeks

  2. Change in Estimated Ulcer Area [ Time Frame: Baseline, 24 weeks ]
    Change in estimated ulcer area from baseline to 24 weeks

  3. Change in Health-related Quality of Life (Short Form 36) [ Time Frame: Baseline, 24 weeks ]
    Mean difference in change in Short Form 36 (SF36) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group.

  4. Change in Health-related Quality of Life (EuroQol-5D 3L) [ Time Frame: Baseline, 24 weeks ]
    Mean difference in change measured by EuroQol 5D (EQ5D 3L) from baseline to 24 weeks. Crude health state scores for each group are not shown (health state is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on health state for that group.

  5. Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire) [ Time Frame: 24 weeks ]
    Mean difference in change in Charing Cross Venous Ulcer Questionnaire (CXVUQ)) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group.

  6. Number of Participants With Adherence to Treatment [ Time Frame: 24 weeks ]
    Adherence to study medication as measured by pill counts (agreement between expected number of tablets remaining after healing and days to healing)

  7. Incidence of Adverse Events at 24 Weeks [ Time Frame: 24 weeks ]
    Total number of different types of adverse events in participants who reported with any untoward medical event



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:

  • Aged 18 years or older
  • Determined to have a venous leg ulcer (clinical indications of venous ulceration, Ankle Brachial Index ≥ 0.8, and other causative aetiologies ruled out)
  • Able to tolerate compression therapy
  • Able to provide written informed consent
  • Confirmation with participant's general practitioner that the participant can take low dose aspirin or placebo.

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • History of myocardial infarction, stroke, transient ischaemic attack, angina or significant peripheral arterial disease
  • History of adverse effects related to aspirin use
  • Currently using aspirin, or other anti-platelet or anticoagulant therapy
  • Opinion of screening medical practitioner at National Institute of Health Innovation that participant has an existing condition or treatment that is a contraindication to use of aspirin or to participation in the 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): NCT02158806


Sponsors and Collaborators
University of Auckland, New Zealand
Health Research Council, New Zealand
Investigators
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Principal Investigator: Andrew Jull, RN PhD School of Nursing, University of Auckland
  Study Documents (Full-Text)

Documents provided by Andrew Jull, University of Auckland, New Zealand:
Study Protocol  [PDF] May 6, 2015
Statistical Analysis Plan  [PDF] February 12, 2015
Informed Consent Form  [PDF] August 22, 2014


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrew Jull, Associate Professor, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT02158806     History of Changes
Other Study ID Numbers: Aspirin4VLU
First Posted: June 9, 2014    Key Record Dates
Results First Posted: January 4, 2019
Last Update Posted: January 4, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We have a plan to share individual participant data with other aspirin for VLU triallists. All other requests for de-identified individual participant data or study documents will be considered where the proposed use aligns with public good purposes, does not conflict with other requests, or planned use by the Trial Steering Committee, and the requestor is willing to sign a data access agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: No limitations to timeframe
Access Criteria: We have a plan to share individual participant data with other aspirin for VLU triallists. All other requests for de-identified individual participant data or study documents will be considered where the proposed use aligns with public good purposes, does not conflict with other requests, or planned use by the Trial Steering Committee, and the requestor is willing to sign a data access agreement.
Keywords provided by Andrew Jull, University of Auckland, New Zealand:
Venous ulcer, varicose ulcer, gravitational ulcer, aspirin
Additional relevant MeSH terms:
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Aspirin
Varicose Ulcer
Leg Ulcer
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