ArticleTrials2026
Adjunctive optical and magnetic stimulation for venous and mixed etiology leg ulcers: protocol for the NAZARÉ multicenter randomized controlled trial.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06528873 (NAZARÉ), which is not on this map. Not yet cited in PubMed.
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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.
NAZARÉ: Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Patients With Chronic Ulcers of Vascular Origin in a Real-world Setting Including Care at Patient's Home, a Prospective Randomized, Controlled, Assessor Blinded, Phase IV, Clinical Trial
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVenous leg ulcers (VLUs) and VLUs associated with peripheral arterial disease (PAD) are common, recurrent, and costly to manage. Adjunctive biophysical therapies may improve healing outcomes when combined with standard of care (SOC). Concurrent optical and magnetic stimulation (COMS) has shown promising mechanistic and preliminary clinical results but there is a lack of robust randomized controlled trials (RCTs).
methodThis novel adjunct using concurrent optical and magnetic stimulation in a multicenter RCT in Europe (NAZARÉ) is a phase IV, post-market, multicenter, parallel-group, superiority randomized controlled trial conducted in Switzerland, France, Germany, and Austria. A total of 122 adults with VLU or mixed leg ulcers (ankle-brachial index > 0.5 and < 1.30 or ankle artery pressure > 60 mmHg), ulcer area 2-50 cm DISCUSSION: This trial will rigorously assess the effectiveness of COMS as an adjunct to standard care for venous and mixed leg ulcers. By targeting chronic wounds and using a pragmatic, multicenter design, it aims to generate robust, generalizable evidence. If effective, COMS could offer a non-invasive, accessible option to enhance healing outcomes and reduce the burden of chronic leg ulcers. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06528873. Registred on 26 July 2024, https://register. CLINICALTRIALS: gov/prs/app/action/SelectProtocol?selectaction=Edit&sid=S000ERKB&uid=U0003LG4 .
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