Cold plasma treatment for chronic wounds in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial explores a non-pharmacologic approach using helium-based cold plasma applied to chronic wounds at different durations, plus dressings with plasma-induced ions. Participants are adults with slow-healing wounds of arterial or venous origin that have persisted for over four weeks and meet size and health criteria. The study aims to observe wound healing progress and safety in an interventional setting without a traditional drug component. Recruitment is centered at a single French hospital site, with eligibility based on wound type, size, and overall health status. Outcomes will inform whether this plasma-based therapy could become a practical option for chronic wound management.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Hospitalier Universitaire d'Orléans, France
  Orléans, France Recruiting

Study contacts

• Study coordinator: Thierry PRAZUCK, PH
• Email: thierry.prazuck@chu-orleans.fr
• Phone: +332 38 51 43 61

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.