Actively Recruiting
Concurrent Optical and Magnetic Stimulation (COMS) for Treating Chronic Vascular Ulcers Including Home Care A Randomized Controlled Phase IV Trial
Led by Sebastian Probst · Updated on 2026-05-08
122
Participants Needed
10
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Sebastian Probst
Lead Sponsor
M
Medical University of Vienna
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic leg and foot ulcers are wounds that do not heal properly over 4 to 8 weeks despite standard care, often due to vascular problems like chronic venous insufficiency and peripheral artery disease. These conditions reduce blood flow, limiting oxygen and nutrients needed for healing, and cause ongoing inflammation and infection. This trial evaluates a new combined optical and magnetic stimulation (COMS) therapy alongside standard care to improve healing, pain, quality of life, and economic outcomes for patients with venous leg ulcers, including those with arterial complications. Participants will be randomly assigned to receive either standard care alone or standard care plus COMS therapy. Standard care includes wound cleaning, dressing changes, debridement, analgesics as needed, and compression therapy according to guidelines. The COMS treatment is applied 2 to 3 times per week for at least 8 weeks using a specialized device during standard care procedures. If patients receive care at home, trained caregivers will perform these treatments. During the 24-week study, participants will have regular assessments to monitor wound healing, pain, quality of life, and ulcer recurrence. Researchers will measure the percent reduction in wound area as the primary outcome after 24 weeks, along with complete wound closure and time to healing. Safety and device usability will also be evaluated. The study is single-blinded with data assessors unaware of group assignments and includes multiple clinical sites across several countries.
CONDITIONS
Brief Title
COMS for Chronic Ulcers Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of venous leg ulcer (VLU) or VLU with peripheral arterial disease (PAD)
- Ankle-brachial index (ABI) between 0.5 and 1.3 or ankle pressure greater than 60 mmHg
- Ulcer size between 2 and 50 cm² after debridement at screening
- Ulcer duration more than 30 days and less than 2 years
- For patients with diabetes, HbA1c less than or equal to 12% at screening
- Able and willing to provide written informed consent prior to study procedures
You will not qualify if you...
- Pregnant or breastfeeding
- Malignancy in the ulcer area
- Use of photosensitizing medication within 30 days prior to screening
- Severe immunosuppression, including chronic corticosteroid use over 10 mg/day prednisolone equivalent
- NYHA class III or IV heart failure
- End-stage renal disease requiring dialysis
- Ulcer area reduction greater than 30% during run-in phase
- Active infection requiring systemic antibiotics at baseline
- Use of advanced wound therapies within 2 weeks prior to screening
- Participation in another interventional clinical trial within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 8 weeks
Participants receive standard of care treatment for chronic vascular ulcers. Those in the intervention group additionally receive Concurrent Optical and Magnetic Stimulation (COMS) treatment 2-3 times per week for at least 8 weeks, unless the wound heals sooner, with a minimum of 16 applications. Treatment occurs during standard care procedures such as dressing changes and debridement, and may be performed at home by a caregiver.
2 to 3 visits per week during treatment
Duration - Up to 16 weeks
Participants are followed for an additional 16 weeks after treatment to monitor wound healing, recurrence, pain, quality of life, and device usability outcomes.
Visits as needed to complete 24-week total study duration
Trial Site Locations
Total: 10 locations
1
Medizinische Universität Graz
Graz, Austria
Not Yet Recruiting
2
Medizinische Universität Wien
Vienna, Austria
Not Yet Recruiting
3
Augustines's Clinic
Malestroit, France
Not Yet Recruiting
4
Universitätsklinikum Essen
Essen, Germany
Not Yet Recruiting
5
University Clinic Hamburg-Eppendorf
Hamburg, Germany
Not Yet Recruiting
6
Jura Hospital
Delémont, Switzerland
Not Yet Recruiting
7
Venenklinik Bellevue
Kreuzlingen, Switzerland
Actively Recruiting
8
Cité Générations
Onex, Switzerland
Not Yet Recruiting
9
Spital Thun
Thun, Switzerland
Not Yet Recruiting
10
University Hospital
Zurich, Switzerland
Not Yet Recruiting
Research Team
S
Sebastian Probst, Prof. Dr.
C
Camille Saini, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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