Trial reportTrials2016
Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- Therapeutic use of highly concentrated COPeerJ · 2026Pooled it
- Aspirin versus placebo for the treatment of venous leg ulcers-a phase II, pilot, randomised trial (AVURT).Trials · 2019Trial
- Correlation of TNF-α, Cys C, and NLRP3 inflammasomes with venous ulcers in patients with lower extremity varicose veins.American journal of translational research · 2023Article
- Association between physical activity levels and healing in people with venous leg ulcers: secondary analysis of prospective cohort data.Frontiers in medicine · 2023Article
- Patient Explanation of Adherence and Non-Adherence to Venous Leg Ulcer Treatment: A Qualitative Study.Frontiers in pharmacology · 2021Article
- Rationale for participation in venous leg ulcer clinical research: Patient interview study.International wound journal · 2020Article
- Randomised controlled trials as part of clinical care: A seven-step routinisation framework proposal.International wound journal · 2019Article
- Barriers and facilitators to participant recruitment to randomised controlled trials: A qualitative perspective.International wound journal · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 9 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVenous leg ulceration is a common and costly problem that is expected to worsen as the population ages. Current treatment is compression therapy; however, up to 50 % of ulcers remain unhealed after 2 years, and ulcer recurrence is common. New treatments are needed to address those wounds that are more challenging to heal. Targeting the inflammatory processes present in venous ulcers is a possible strategy. Limited evidence suggests that a daily dose of aspirin may be an effective adjunct to aid ulcer healing and reduce recurrence. The Aspirin in Venous Leg Ulcer study (ASPiVLU) will investigate whether 300-mg oral doses of aspirin improve time to healing. METHODS/
designThis randomised, double-blinded, multicentre, placebo-controlled, clinical trial will recruit participants with venous leg ulcers from community settings and hospital outpatient wound clinics across Australia. Two hundred sixty-eight participants with venous leg ulcers will be randomised to receive either aspirin or placebo, in addition to compression therapy, for 24 weeks. The primary outcome is time to healing within 12 weeks. Secondary outcomes are ulcer recurrence, wound pain, quality of life and wellbeing, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks. DISCUSSION: The ASPiVLU trial will investigate the efficacy and safety of aspirin as an adjunct to compression therapy to treat venous leg ulcers. Study completion is anticipated to occur in December 2018.
trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12614000293662.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.