NAZARÉ
Research type
Research Study
Full title
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, post-marketing clinical trial
IRAS ID
367632
Contact name
Sebastian Probst
Contact email
Sponsor organisation
University of Applied Sciences and Arts Western Switzerland
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-07-64-029615, Project number (BASEC): 2024-D0096
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Chronic leg ulcers are common and can be very distressing. They often take months to heal, cause pain, reduce mobility and independence, and require frequent clinic or home visits. These wounds are usually caused by problems with reflux within the veins causing high pressure around the ankle leading to chronic inflammation and subsequent skin breakdown. Even when people receive good evidence-based care many ulcers heal very slowly or not at all.
This study is looking at whether adding a new, non-invasive medical device called COMS One to usual care can help these wounds heal faster. The COMS One device gives off very gentle light and low-level magnetic signals. These are thought to support the body’s natural healing processes by improving blood flow, reducing long-term inflammation, and helping skin cells repair themselves. The device does not involve needles, medicines, heat, or radiation, and is already approved for clinical use.
Around 122 adults with long-standing venous leg ulcers take part across several European countries, including the UK. Participants will be randomly placed into one of two groups. One group will receive standard wound care alone, while the other will receive standard care plus COMS One treatment. The device will be used for 16 minutes, two to three times per week, usually during normal dressing changes, either in clinic or at home.
The study will follow participants for up to 24 weeks. Researchers will measure how quickly wounds heal, how much pain people experience, and how their quality-of-life changes. The study will also look at safety, ease of use, and how the treatment affects healthcare visits and dressing changes.
The results will help determine whether COMS One provides real, meaningful benefits for patients and could improve everyday care for people living with chronic leg ulcers.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
26/PR/0287
Date of REC Opinion
24 Apr 2026
REC opinion
Further Information Favourable Opinion