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
|Condition or disease||Intervention/treatment||Phase|
|Venous Leg Ulcer||Drug: Aspirin Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|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.|
|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|
150 mg capsule once daily for up to 24 weeks
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
Matching placebo capsule containing inert bulking agent
- Time to Complete Healing of Reference Ulcer [ Time Frame: 24 weeks ]Time to event (complete healing defined as intact skin with absence of scab)
- 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
- Change in Estimated Ulcer Area [ Time Frame: Baseline, 24 weeks ]Change in estimated ulcer area from baseline to 24 weeks
- 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.
- 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.
- 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.
- 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)
- 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
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
|Principal Investigator:||Andrew Jull, RN PhD||School of Nursing, University of Auckland|