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Cold plasma could heal stubborn wounds faster

NCT ID NCT07564739

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a cold helium plasma device is safe and tolerable for people with chronic wounds, such as leg ulcers or pressure sores. About 40 adults with wounds that have not healed for over 4 weeks will receive the treatment. The goal is to see if cold plasma can reduce inflammation and help wounds heal faster without causing harm.

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

About 40 people

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

Started

May 2026

Expected to finish

Sep 2027

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: 1. Men or women. 2. Aged 18 years or older. 3. Chronic wound or ulceration. 4. Wound measuring 5 to 100 cm² of arterial or venous origin. 5. Evolution \> 4 weeks. 6. With less than 30% necrosis. 7. Able to give informed written consent. 8. Blood pregnancy test for women of childbearing age. Exclusion Criteria: 1. Tumor wounds 2. Dialysis 3. Patients requiring surgical revascularization 4. Severe heart failure (NYHA III-IV) or acute myocardial infarction. 5. Wounds or ulcers located less than 10 cm from the patient's airways and respiratory tract 6. Severe renal failure defined as creatinine clearance \<20 mL/min calculated according to the MDRD 7. Patients with severe hepatic impairment (class C) according to the Child Pugh score 8. Unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormality. 9. Active malignant tumor 10. Patients who, in the investigator's opinion, are at significant risk of suicide 11. Any pre-existing physical or mental condition that may interfere with the patient's ability to comply with the administration schedule and/or protocol assessments, or that may compromise the patient's safety. 12. Persons covered by Articles L.1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (including minors and protected adults) 13. Protected person (under guardianship or curatorship) 14. Person under judicial protection 15. Persons deprived of their liberty 16. Persons not affiliated with a social security system 17. Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study. 18. Patients participating in another clinical trial evaluating a treatment 19. Allergy to the dressings used in the trial

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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.

How to take part

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

  1. The places running it

    1 site. 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

  • Centre Hospitalier Universitaire d'Orléans, France

    RECRUITING

    Orléans, 45000, France

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