Einschlusskriterien

* 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)

Ausschlusskriterien

* 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

Studienteilnehmende Mindestalter

Jahr(e)

Geschlecht

Divers/Männlich/Weiblich

Indikation

Diverse

Medizinischer Befund

Venous Leg Ulcer Wound Heal Magnetic Field Exposure