COMS for Chronic Ulcers Treatment

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

September 30, 2026

Conditions
Venous Leg UlcerWound HealMagnetic Field Exposure
Interventions
COMBINATION_PRODUCT

Concurrent optical and magnetic stimulation (COMS) treatment

"COMS treatment will be performed 2-3 times per week for at least 8 weeks, unless the wound heals sooner, with a minimum of 16 applications. Missed sessions can be made up in the 4-week follow-up period. Treatment will occur during standard care procedures, including dressing changes and debridement, and will follow these steps:~Remove old dressing Apply analgesic if necessary Perform debridement if necessary Cleanse the wound Apply COMS One device Apply new dressing Apply compression therapy as per study procedures (section 6.1)~If the patient is at home, a caregiver will perform this procedure. Study staff, including the PI, nurses, and caregivers, will receive training and a step-by-step document on using the COMS One device."

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medical University of Vienna

OTHER

collaborator

University Hospital, Geneva

OTHER

collaborator

Medical Centre Cité Générations

UNKNOWN

collaborator

Jura Hospital

UNKNOWN

collaborator

Clinique des Augustines

UNKNOWN

collaborator

Venenklinik Bellevue

OTHER

collaborator

Universitätsklinikum Hamburg-Eppendorf

UNKNOWN

collaborator

Medical University of Graz

OTHER

collaborator

Universität Duisburg-Essen

UNKNOWN

collaborator

University Hospital, Zürich

UNKNOWN

collaborator

Hospital Thun

UNKNOWN

lead

Sebastian Probst

OTHER

NCT06528873 - COMS for Chronic Ulcers Treatment | Biotech Hunter | Biotech Hunter