Combined optical and magnetic therapy for chronic leg and foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Venenklinik Bellevue
  Kreuzlingen, Switzerland Recruiting
• 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

Study contacts

• Study coordinator: Sebastian Probst, Prof. Dr.
• Email: sebastian.probst@hesge.ch
• Phone: 122-558-6563

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.