Combined optical and magnetic therapy for chronic leg and foot ulcers

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

This trial tests whether combined light and magnetic stimulation can help adults with chronic venous leg or foot ulcers heal faster when added to usual wound care.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 122 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: School of Health Sciences Geneva (other)
• Locations: 10 sites (Graz and 9 other locations)
• Trial ID: NCT06528873 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional trial delivers concurrent optical and magnetic stimulation (COMS) to chronic venous leg and foot ulcers alongside standard of care at academic centers. Adults with venous leg ulcers (with or without peripheral arterial disease) who meet ABI, ulcer size (2–50 cm²) and duration (>30 days, <2 years) criteria are eligible, while those with active infection, recent advanced wound therapies, or severe immunosuppression are excluded. Treatments are applied over a treatment period with regular clinic visits and wound assessments to measure healing and safety outcomes. The trial aims to determine real-world safety and effectiveness of adding COMS to current wound-care practices.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic venous leg or foot ulcers (2–50 cm² and longer than 30 days but less than 2 years), ABI 0.5–1.3 or ankle pressure >60 mmHg, and who can consent and comply with clinic visits.

Not a fit: Patients with actively infected ulcers needing systemic antibiotics, severe immunosuppression, ulcer-area malignancy, recent advanced wound therapies, or on photosensitizing medications are unlikely to benefit from COMS in this trial.

Why it matters

Potential benefit: If effective, COMS could speed wound closure, reduce infections, and lower the need for advanced interventions for chronic venous leg and foot ulcers.

How similar studies have performed: Small trials and preclinical studies of low-level light and electromagnetic therapies have reported mixed but sometimes promising results for wound healing, though large definitive trials remain limited.

Eligibility criteria

Inclusion Criteria:

Age ≥ 18 years Clinical diagnosis of venous leg ulcer (VLU) or VLU with peripheral arterial disease (PAD) Ankle-brachial index (ABI) 0.5-1.3 or ankle pressure \> 60 mmHg Ulcer size 2-50 cm² after debridement at screening Ulcer duration \> 30 days and \< 2 years For patients with diabetes: HbA1c ≤ 12% at screening Able and willing to provide written informed consent prior to study procedures

Exclusion Criteria:

Pregnant or breastfeeding Malignancy in the ulcer area Use of photosensitizing medication within 30 days Severe immunosuppression (including chronic corticosteroid use \> 10 mg/day prednisolone equivalent) NYHA class III or IV heart failure End-stage renal disease requiring dialysis Ulcer area reduction \> 30% during run-in phase Active infection requiring systemic antibiotics at baseline Use of advanced wound therapies (e.g., negative pressure wound therapy, skin substitutes, hyperbaric oxygen) within 2 weeks prior to screening Participation in another interventional clinical trial within 30 days

Where this trial is running

Graz and 9 other locations

• 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)

Study contacts

• Study coordinator: Sebastian Probst, Prof. Dr.

Conditions: Venous Leg Ulcer, Wound Heal, Magnetic Field Exposure, Venous leg ulcer, optical stimulation, magnetic stimulation