RecruitingPHASE4INTERVENTIONAL

COMS for Chronic Ulcers Treatment

This research is investigating a new treatment called COMS (concurrent optical and magnetic stimulation) for long-lasting leg and foot ulcers. These are wounds that take a very long time, usually over a month, to heal, often due to poor blood flow. COMS uses a combination of light and magnetic fields to encourage healing by improving how cells work, increasing blood flow, and reducing inflammation. The study wants to see if adding COMS to standard care is better than standard care alone for healing wounds, reducing pain, and improving quality of life for people with venous leg ulcers, sometimes combined with peripheral artery disease.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Sebastian Probst

Enrolment target

122

Start

01 Oct 2025

Estimated completion

30 Sep 2026

Venous Leg Ulcer Wound Heal Magnetic Field Exposure

What is this study about?

Imagine you have a cut or scrape, and it usually heals up in a week or two. But for some people, especially those with conditions like poor blood circulation—often called venous insufficiency or peripheral artery disease—wounds on their legs and feet can take months or even years to heal. These are called chronic ulcers, and they can be painful, get infected, and seriously affect daily life. The main problem is that not enough blood, oxygen, and nutrients get to the wound, making it hard for the body to repair itself.

Currently, doctors treat these ulcers with things like special bandages, compression stockings, and sometimes surgery to improve blood flow. These methods help, but many ulcers still struggle to heal completely. This 'COMS' study is looking at a new approach that might give the body an extra boost. COMS stands for Concurrent Optical and Magnetic Stimulation. It's a fancy way of saying it uses both light and gentle magnetic fields on the wound.

The idea behind COMS is that these light and magnetic fields can help the cells in the wound area work better. They might improve the cells' energy production, encourage new blood vessels to grow, and reduce swelling and inflammation. By doing this, COMS aims to speed up the natural healing process that the body is struggling with. This study is important because if COMS proves to be effective, it could offer a new and better way to help people with these stubborn ulcers heal.

Key takeaways

This study explores a new treatment (COMS) for stubborn leg ulcers.
COMS uses light and magnetic fields to boost natural healing.
The study compares COMS plus usual care against usual care alone.
It aims to see if COMS helps wounds heal faster, reduces pain, and improves life quality.
Participation involves regular check-ups and assessments.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over, and have a leg ulcer usually caused by vein problems (venous leg ulcer), possibly with additional circulation issues (peripheral arterial disease). Your ulcer needs to be between 2 and 50 square centimetres in size after any initial cleaning, and it must have been present for more than 30 days but less than two years.

There are also a few things that would mean you couldn't join. For instance, if you are pregnant or breastfeeding, or if you have cancer in the ulcer area. If you use certain strong medications that weaken your immune system, or if your heart or kidneys are severely affected by other conditions, you wouldn't be able to participate. Also, if your ulcer has already started to heal significantly just before the study begins, or if you're currently using advanced wound treatments, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a leg ulcer usually caused by vein problems?
Has your ulcer been present for more than 30 days but less than two years?
Is your ulcer between 2 and 50 square centimetres in size (after any cleaning)?
Are you NOT pregnant or breastfeeding?
Do you NOT have cancer in the ulcer area or severe heart/kidney problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups: either receiving the COMS treatment along with your usual care, or receiving only your usual care. You would have regular visits to the clinic for assessments of your ulcer, including measurements of its size, and to check your overall health and any pain you might be experiencing. The study will also ask about your quality of life and how easy the COMS device is to use, if you are in that group. The total duration of your participation in the study, including follow-up, will be explained by the study team.

Potential risks and benefits

Participating in this study might offer the benefit of potentially faster and more complete healing of your ulcer, reduced pain, and an improved quality of life if the COMS treatment proves effective. However, as with any new treatment, there might be unknown side effects or the treatment might not work for you. There is also no guarantee that your ulcer will heal or improve. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Medizinische Universität Graz
Verified postcode
Graz, Austria· Not yet recruiting
Medizinische Universität Wien
Verified postcode
Vienna, Austria· Not yet recruiting
Augustines's Clinic
Verified postcode
Malestroit, France· Not yet recruiting
Universitätsklinikum Essen
Verified postcode
Essen, Germany· Not yet recruiting
University Clinic Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Not yet recruiting
Jura Hospital
Verified postcode
Delémont, Switzerland· Not yet recruiting
Venenklinik Bellevue
Verified postcode
Kreuzlingen, Switzerland· Recruiting
Cité Générations
Verified postcode
Onex, Switzerland· Not yet recruiting
Spital Thun
Verified postcode
Thun, Switzerland· Not yet recruiting
University Hospital
Verified postcode
Zurich, Switzerland· Not yet recruiting

Common questions

What is a chronic leg ulcer?

It's a wound on your leg or foot that hasn't healed properly after more than a month, often due to poor blood circulation.

What is COMS treatment?

COMS stands for Concurrent Optical and Magnetic Stimulation. It's a new treatment that uses special light and gentle magnetic fields to try and help your ulcer heal.

Will I still get my usual wound care?

Yes, everyone in the study will continue to receive their standard, usual wound care, no matter which group they are in.

Is the COMS treatment painful?

The study aims to use gentle magnetic fields and light, and any discomfort will be monitored closely.

How long will the study last for me?

The study team will explain the exact duration of your involvement, including treatment and follow-up, during your initial visit.

How to find out more

Sebastian Probst, Prof. Dr.

sebastian.probst@hesge.ch 122-558-6563 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.