COMS for Chronic Ulcers Treatment

NCT06528873 | Recruiting Phase 4 DMC

• 2 other identifiers: NAZARÉPIOMIC
• Study Type: interventional
• Target: 122
• Locations: 4 countries
• Sites: 10

Brief Summary

Chronic leg and foot ulcers are defined as wounds that fail to heal in a timely manner, typically persisting for over 4 to 8 weeks without substantial healing despite standard care. These ulcers often result from macro- and microvascular disorders, the most common being chronic venous insufficiency (CVI), alone or with peripheral artery disease (PAD) or microangiopathy. Despite different causes, chronic vascular-origin wounds share similar biological traits and require the same physiological processes for healing. Vascular issues hinder blood perfusion, reducing oxygen, nutrients, and growth factors, leading to decreased energy metabolism and impaired cell functions necessary for proliferation, extracellular matrix production, angiogenesis, and tissue regeneration. Reduced blood supply also limits leukocyte function, compromising the immune response and leading to persistent inflammation and infection. Consequently, these wounds cannot effectively heal, showing prolonged inflammation, persistent infections, and cellular senescence. Best practice wound care includes compression therapy and physical activity for venous ulcers, and angioplasty, surgery, or bypass for arterial ulcers. These treatments aim to improve blood flow, reduce venous stasis, and enhance venous return. Compression therapy and physical activity lower hydrostatic pressure in the lower limb, while angioplasty and surgery remove arterial blockages or create new blood flow routes. Recent studies highlight the role of mechano-sensitive (MS) ion channels in skin cell processes and their dysfunction in dermatological disorders. Magnetic stimulation can activate MS TRCP1 channels, enhancing mitochondrial respiration and mitochondriogenesis via the Ca2+/CalModulin(CaM)/NFAT/PGC-1α pathway. Ca2+-activated calmodulin also catalyzes nitric oxide (NO), promoting vasodilation and tissue perfusion. Bimodal red and near-infrared photobiomodulation can further increase mitochondrial respiration and ATP production by activating Cytochrome C oxidase and mitigating NO-induced downregulation. This synergistic mechanism of concurrent optical and magnetic stimulation (COMS) may amplify Ca2+ and NO-mediated processes like cell proliferation, migration, vasodilation, and angiogenesis while resolving inflammation. Thus, COMS may offer a promising therapy for chronic, inflammation-prone wounds. The effectiveness of COMS has yet to be validated in large-scale studies. This proposal aims to assess the impact of COMS therapy combined with standard care versus standard care alone on healing, wound closure, recurrence, pain, quality of life, economic outcomes, and device usability in patients with venous leg ulcers (VLU) and VLU associated with PAD in a large-scale multicentric randomized controlled trial.

Conditions

Venous Leg Ulcer; Wound Heal; Magnetic Field Exposure

Keywords

Venous leg ulcer; optical stimulation; magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Percent wound area reduction

  Percent wound area reduction (PWAR) at week 12 will be measured from pictures of the wound taken with ImitoWound research application. PWAR is computed as (Wound area at baseline - Wound area at 12 weeks) / Wound area at baseline. The picture of the wound will be taken after dressing removal, wound debridement (if applicable) and wound cleansing. ImitoWound research App will be used in an iPad as instructed in supplier's wound imaging and measurement guidelines. The camera of the iPad will be positioned 20 to 30 cm away from and parallel to the wound. A calibration marker (quick response \[QR\] code) will be positioned next to and in the same plane of the wound, and a photograph will be taken after recognition of the QR code by the Imito App, automatic wound measurement will take place. Study nurses will receive concise training and a working instruction with step-by-step procedure on how to use Imito App. (See Appendices) Each wound contour will then be checked and confirmed by an expe

  24 weeks

Secondary Outcomes (6)

• Complete wound closure

  24 weeks

• Percent Wound Area Reduction (PWAR

  24 weeks

• Change in Pain assessment

  24 weeks

• Change in Wound-QoL

  24 weeks

• Median time-to-healing

  24 weeks

Study Arms (2)

usual care

NO INTERVENTION

Standard of Care treatment will be performed according to a provided standard of care manual according to most recent guidelines followed at each corresponding site (EWMA , S3-Leitlinie,…) and will proceed as follows: * Removal of old dressing * Application of analgesic if necessary * Debridement if necessary * Wound cleansing * Application of new dressing (according to the wound healing phases, medical prescription) * Application of compression therapy according to study standardized procedure (details in section 6.1). In the case the participant is at home, this procedure will be performed by a caregiver.

COMS Therapy

EXPERIMENTAL

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.

Combination Product: Concurrent optical and magnetic stimulation (COMS) treatment

Interventions

Concurrent optical and magnetic stimulation (COMS) treatment COMBINATION_PRODUCT

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.

COMS Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Clinique des Augustines: collaborator
• Venenklinik Bellevue: collaborator
• Sebastian Probst: lead
• Medical University of Vienna: collaborator
• University Hospital, Geneva: collaborator
• Jura Hospital: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Medical University of Graz: collaborator
• Universität Duisburg-Essen: collaborator
• University Hospital, Zürich: collaborator
• Hospital Thun: collaborator
• Medical Centre Cité Générations: collaborator

Study Sites (10)

Medizinische Universität Graz

Graz, Austria

NOT YET RECRUITING

Medizinische Universität Wien

Vienna, Austria

NOT YET RECRUITING

Augustines's Clinic

Malestroit, France

NOT YET RECRUITING

Universitätsklinikum Essen

Essen, Germany

NOT YET RECRUITING

University Clinic Hamburg-Eppendorf

Hamburg, Germany

NOT YET RECRUITING

Jura Hospital

Delémont, Switzerland

NOT YET RECRUITING

Venenklinik Bellevue

Kreuzlingen, Switzerland

RECRUITING

Cité Générations

Onex, Switzerland

NOT YET RECRUITING

Spital Thun

Thun, Switzerland

NOT YET RECRUITING

University Hospital

Zurich, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sebastian Probst, Prof. Dr.

CONTACT

122-558-6563; sebastian.probst@hesge.ch

Camille Saini, Dr.

CONTACT

122-558-5274; camille.saini@hesge.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Tissue Viability and Wound Care

Model Details: The COMS One therapy system is a CE-marked medical device for treating chronic leg and foot ulcers. It uses electromagnetic fields and photons non-invasively, non-ionizingly, non-thermally, and non-medicinally. The device transmits extremely low frequency (ELF) electromagnetic fields using a coil connected to a signal generator. It emits twenty trapezoid-shaped bursts per second, with the field's polarity switching every 2 minutes over a 16-minute session. The flux densities range from 0.4 mT to 1.6 mT in four-minute intervals. Photons are delivered via LEDs with peak wavelengths of 660 nm and 830 nm, targeting cytochrome C Oxidase. The light pulses at 1000 Hz, providing a radiant exposure of 2-5 J/cm² at a 1 cm distance from the skin. Technical details are in the IFU (100.0053\_C\_IfU).

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: from 2027 until 2029
• Access Criteria: all researchers

Locations

AU (2); FR (1); DE (2); CH (5)