Adjunctive optical and magnetic stimulation for venous and mixed etiology leg ulcers: protocol for the NAZARÉ multicenter randomized controlled trial.

IF 2.1 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2026-06-29 DOI:10.1186/s13063-026-09859-1

Sebastian Probst, Camille Saini, Alessio Stefanelli, André Frei, Ewa Klara Stuermer, Joachim Dissemond, Lars-Peter Kamolz, Benedikt Weber, Jean-Paul Lembelembe, Jürg Traber, Dieter Mayer, Thomas Zehnder, Dave Baer, Claudio Ruzza, Jürg Hafner

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引用次数: 0

Abstract

Background: Venous 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).

Method: This 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 cm², and ulcer duration > 30 days and < 2 years will be enrolled. Following a 2-week run-in to confirm < 30% area reduction under SOC, participants will be randomized 1:1 to SOC + COMS or SOC alone. The primary outcome is percentage wound area reduction (PWAR) at week 12, assessed by blinded evaluators using standardized digital planimetry. Secondary outcomes include complete closure, time-to-healing, pain, health-related quality of life, recurrence, and healthcare resource use. Missing outcome data will primarily be analyzed as observed and may be addressed using multiple imputation under the assumption of data being missing at random.

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 .

查看原文本刊更多论文

辅助光学和磁刺激治疗静脉和混合病因性腿部溃疡：NAZARÉ多中心随机对照试验方案。

背景：下肢静脉性溃疡（VLUs）和与外周动脉疾病（PAD）相关的VLUs是一种常见、反复发作且治疗费用昂贵的疾病。当与标准护理（SOC）相结合时，辅助生物物理疗法可以改善愈合结果。并行光磁刺激（COMS）已显示出良好的机制和初步临床结果，但缺乏可靠的随机对照试验（rct）。方法：在欧洲进行的一项多中心随机对照试验（NAZARÉ）中，使用同步光和磁刺激的新辅助方法是在瑞士、法国、德国和奥地利进行的一项上市后、多中心、平行组、优势随机对照试验的IV期。共有122名患有VLU或混合性腿部溃疡（踝关节-肱指数0.5和60 mmHg），溃疡面积2-50 cm2，溃疡持续时间> 30天的成年人。讨论：本试验将严格评估COMS作为静脉性和混合性腿部溃疡标准护理辅助的有效性。通过针对慢性伤口和使用实用的多中心设计，它旨在产生可靠的，可推广的证据。如果有效，COMS可以提供一种非侵入性的、可获得的选择，以提高愈合效果并减轻慢性腿部溃疡的负担。试验注册号：ClinicalTrials.gov NCT06528873。注册于2024年7月26日https://register.Clinicaltrials: gov/prs/app/action/SelectProtocol?selectaction=Edit&sid=S000ERKB&uid=U0003LG4。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.