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Venous Leg UlcerPhase 3Aspirin4VLUNCT02158806

Low Dose Aspirin for Venous Leg Ulcers

A Phase 3 study testing Aspirin in people with Venous Leg Ulcer, run by University of Auckland, New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Leg Ulcer
What is being tested?
Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
251 participants
Where
No sites listed yet
Study dates
Mar 2015to 31 Mar 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Low Dose Aspirin for Venous Leg Ulcers: a Randomised Trial

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.

Read the 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.

Being tested
Aspirin, Placebo
Keywords
Venous ulcer, varicose ulcer, gravitational ulcer, aspirin
Medical subject headings
Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    150 mg aspirin in capsule form once daily for up to 24 weeks

  • PlaceboDrug

    Matching placebo capsule containing inert bulking agent

Study groups in NCT02158806
Study groupRoleWhat they receive
AspirinExperimental150 mg capsule once daily for up to 24 weeks
Receives: Drug: Aspirin
Inert capsulePlacebo comparatorMatching capsule once daily for up to 24 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Complete Healing of Reference Ulcer

    Time to event (complete healing defined as intact skin with absence of scab)

    Measured: 24 weeks

Secondary outcomes (7)

  1. Number of Participants With Healed Venous Leg Ulcers

    Number of participants in each arm with completely healed reference ulcers at 24 weeks

    Measured: 24 weeks

  2. Change in Estimated Ulcer Area

    Change in estimated ulcer area from baseline to 24 weeks

    Measured: Baseline, 24 weeks

  3. Change in Health-related Quality of Life (Short Form 36)

    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.

    Measured: Baseline, 24 weeks

  4. Change in Health-related Quality of Life (EuroQol-5D 3L)

    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.

    Measured: Baseline, 24 weeks

  5. Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire)

    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.

    Measured: 24 weeks

  6. Number of Participants With Adherence to Treatment

    Adherence to study medication as measured by pill counts (agreement between expected number of tablets remaining after healing and days to healing)

    Measured: 24 weeks

  7. Incidence of Adverse Events at 24 Weeks

    Total number of different types of adverse events in participants who reported with any untoward medical event

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2014 (estimated)
  2. Study startMar 2015
  3. Primary completion31 Mar 2017
  4. Study completion31 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02158806
Sponsor's protocol ID
Aspirin4VLU
Acronym
Aspirin4VLU
Status last verified
Dec 2018
First submitted
5 Jun 2014
Last updated
4 Jan 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Jull A, Wadham A, Bullen C, Parag V, Kerse N, Waters J. Low-dose aspirin as an adjuvant treatment for venous leg ulceration: study protocol for a randomized controlled trial (Aspirin4VLU). J Adv Nurs. 2016 Mar;72(3):669-79. doi: 10.1111/jan.12864. Epub 2015 Dec 28.

    PubMed 26708314

  • Jull A, Wadham A, Bullen C, Parag V, Kerse N, Waters J. Low dose aspirin as adjuvant treatment for venous leg ulceration: pragmatic, randomised, double blind, placebo controlled trial (Aspirin4VLU). BMJ. 2017 Nov 24;359:j5157. doi: 10.1136/bmj.j5157.

    PubMed 29175902

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aspirin in people with Venous Leg Ulcer, run by University of Auckland, New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Complete Healing of Reference Ulcer (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02158806, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.

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