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Could light and magnets finally heal stubborn leg wounds?

NCT ID NCT06528873

Disease control Sponsor: Sebastian Probst Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device that uses light and magnets (COMS) to help heal chronic leg ulcers. About 122 people with venous leg ulcers will receive either standard care plus COMS or standard care alone. The goal is to see if the device speeds up wound healing and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
concurrent optical and magnetic stimulation (COMS) device
What this could lead to
If successful, COMS could become a new, non-invasive way to help chronic leg ulcers heal faster when added to standard care.
What could go wrong
This is a relatively small, early-phase trial (122 people). The device may not prove more effective than standard care alone, and results may not apply to all ulcer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 122 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Magnetic field exposure Venous leg ulcer Wound heal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Augustines's Clinic

    NOT_YET_RECRUITING

    Malestroit, France

  • Cité Générations

    NOT_YET_RECRUITING

    Onex, Switzerland

  • Jura Hospital

    NOT_YET_RECRUITING

    Delémont, Switzerland

  • Medizinische Universität Graz

    NOT_YET_RECRUITING

    Graz, Austria

  • Medizinische Universität Wien

    NOT_YET_RECRUITING

    Vienna, Austria

  • Spital Thun

    NOT_YET_RECRUITING

    Thun, Switzerland

  • University Clinic Hamburg-Eppendorf

    NOT_YET_RECRUITING

    Hamburg, Germany

  • University Hospital

    NOT_YET_RECRUITING

    Zurich, Switzerland

  • Universitätsklinikum Essen

    NOT_YET_RECRUITING

    Essen, Germany

  • Venenklinik Bellevue

    RECRUITING

    Kreuzlingen, Switzerland

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