Cold plasma could heal stubborn wounds faster
NCT ID NCT07564739
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre Hospitalier Universitaire d'Orléans, France
RECRUITINGOrléans, 45000, France
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Other studies related to the condition(s) this trial covers.
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- Glow-in-the-Dark wound camera study fizzles out