COMS for Chronic Ulcers Treatment

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