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NCT06528873

PHASE4

COMS for Chronic Ulcers Treatment

Sponsor: Sebastian Probst

View on ClinicalTrials.gov

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.

Official 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, Phase IV, Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2025-06-01

Completion Date

2026-09-30

Last Updated

2025-05-14

Healthy Volunteers

Conditions

Venous Leg Ulcer Wound Heal Magnetic 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.

Inclusion Criteria: * Diagnosed leg Ulcer of vascular origin (venous or mixed venous-arterial) without severe arterial insufficiency. Diagnosis of leg ulcer is based on angiological tests carried out at a given time, regardless of whether it is recent or older. * Ulcer area between 2 - 50 cm2 after debridement * Patients are older than 18 years of age. * Chronic ulcer(s) with duration greater than 30 days and less than 2 years (continuous duration) * If more than one ulcer is present, the target ulcer may be chosen based on the investigator's preference. However, the target ulcer must have a spatial distance of at least 5cm from all other ulcers so that measurements can be carried out accurately even in case an ulcer is growing in size. * For diabetic patients: well-controlled diabetic mellitus (HbA1c ≤ 8%, historical results \<3 months is acceptable) * Adequate vascular perfusion as evidence by: ABI \> 0.5 and \< 1.30, ankle artery pressure \>60 mmHg (historical results \<3 months is acceptable). * Women of childbearing age must agree to use adequate method of contraception * Informed consent as documented by signature of the participant or a LAR, and being able to understand German or French language and follow the study protocol (cognition) Exclusion Criteria: * Women who are pregnant or breastfeeding (Women of childbearing potential need to perform a pregnancy test (urine test) within 24 hours prior to the study intervention and need at least one simple acceptable contraceptive method) * Suspected skin cancer, or documented history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated. * Use of photosensitizing agents or medications * The patient is undergoing severe endogenous or drug immunosuppression * Decompensated heart failure (NYHA III-IV) * Patient with chronic renal insufficiency currently undergoing dialysis. * Wounds with \>30% wound area reduction in the last 2 weeks while receiving optimal standard of care (SOC) prior to randomization * The patient is receiving systemic antibiotic treatment or is receiving/needing antibiotic wound therapy in/near the wound at inclusion * The patient has received one of the following treatments in the last 2 weeks: Arterial interventions such as angioplasty or vascular surgery. Venous Interventions including venous angioplasty, sclerotherapy, stenting, or endovenous thermal or non-thermal ablation. * Cell and tissue based therapies such as punch \& skin grafts in general, placental based allografts, autologous skin substitutes, cellular and acellular dermal matrix, platelet rich plasma and stem cell therapies * Advanced wound care therapies such as shock wave, cold plasma, electric stimulation, ultrasound, negative pressure wound therapy, nanotechnologies, oxygen therapies * Participants that were previously included in this clinical trial