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Cold plasma could speed up healing of chronic wounds

NCT ID NCT05855499

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 15, 2026 · Updated 5 times

Summary

This study tests whether adding cold plasma therapy to standard wound care helps heal large chronic leg ulcers faster. About 120 adults with non-healing wounds will receive either standard care alone or standard care plus a 4-week plasma treatment. The main goal is to see if the wounds shrink more with plasma therapy.

What this could mean

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

Active substance
cold plasma
What this could lead to
If it works, this could offer a faster, easier way to treat large chronic wounds that are hard to heal with standard care alone.
What could go wrong
This is a mid-stage trial with 120 people, so results may not apply to everyone. The added benefit of plasma over standard care may be small or none.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: Inclusion criteria are divided into patient-specific and wound-specific criteria. Patient Criteria: * Patient must be at least 18 years old (legal age) and legally competent * The patient has at least one diagnosed chronic (existing for at least 8 weeks), non-healing wound due to a UCA or UCV on the lower leg, below the knee * There is a signed consent form dated by the patient's own hand Wound Criteria: * In case of multiple wounds, the largest wound by area will be included in the study if it meets all inclusion criteria and no exclusion criteria and is suitable for use of the investigational product. The target wound is at least 2 cm away from the other wound(s) * The wound was diagnosed - at the time of planned inclusion - more than 8 weeks ago and classified as a chronic wound * The initial wound area is 5 cm²-100 cm2 * The wound can be enclosed completely by the plasma applicator (10 cm x 10 cm) * The wound is not undermined * The wound is located on the lower leg Exclusion Criteria: The exclusion criteria are divided into patient-specific and wound-specific criteria. Patient Criteria: * The patient is younger than 18 years and/or lacks legal capacity * The patient has already participated in this study * The patient is already participating in another interventional study * Pregnant or breastfeeding patients * The patient has an implanted pacemaker, defibrillator or other active implants * The patient has a light/sun allergy * The patient has a silicone allergy * The patient has had a thrombosis within the last 3 months * The patient has a systemic and/or chronic infectious disease (e.g., HIV, tuberculosis, hepatitis) * The patient has a tumour disease * An ongoing or recently completed chemotherapy or radiotherapy * The patient is undergoing severe endogenous or drug immunosuppression * The patient is receiving systemic antibiotic treatment or is receiving/needing antiseptic/antibiotic wound therapy in/near the wound * The patient does not have the necessary revascularization (paVK) * The patient requires vital instrumental monitoring in the sense of "basic monitoring": near-patient respiratory gas measurement (oxygen, carbon dioxide and inhalation anaesthetic), pulse oximeter, ECG monitoring, blood pressure measurement (non-invasive), an oscillometric blood pressure measurement with automatic mode * Existing alcohol or drug abuse * The patient requires dialysis Wound Criteria: * The wound is not a chronic wound as defined by study protocol * The wound is difficult to access or close to exposed vessels * The wound is critically colonized or infected * Acute infections in the wound area (radius 5 cm) * The wound is bleeding profusely. This does not include bleeding immediately after debridement * The wound is undermined * The wound is located at the knee or above

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Charité Universitätsmedizin Berlin

    Berlin, State of Berlin, 10117, Germany

  • Katholisches Klinikum Bochum

    Bochum, North Rhine-Westphalia, 44805, Germany

  • Universitäts-Hautklinik Tübingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • Verbund Thüringen-Kliniken "Georgius Agricola"

    Saalfeld, Thuringia, 07318, Germany

  • Zentrum Regensburg

    Regensburg, Bavaria, 93047, Germany

  • Zentrum Rothenaicher

    München, Bavaria, 81927, Germany