Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds (PLASMA-SAFE)

Chronic wounds affect many patients, with no downward trend in recent decades. This is a significant economic and social issue, and this condition has an impact on functional disabilities and quality of life, especially among the elderly. Diagnosis is essentially clinical, and there are many causes, but 90% of leg ulcers, for example, are primarily vascular in origin. There are wounds of traumatic, post-operative, and vascular origin, as well as pressure sores. The main purpose of invasive tests is to objectively determine the cause (arterial damage) or to check for underlying osteitis. Chronic wounds are usually infected or colonized by bacteria from the skin and digestive flora. There is no indication for antibiotic therapy in the treatment of wounds. Nursing staff play an important role in therapeutic management, which must be carried out in harmony with other healthcare professionals, such as general practitioners and specialists. This management has two main goals: to accelerate the epidermalization of chronic wounds, or even their healing, and to limit local and general complications, the recurrence of which remains the most difficult to control. There are many types of healing dressings available, adapted to each type of ulceration: fibrinous, necrotic, superinfected, etc.

Nevertheless, innovative solutions can accelerate healing, thereby reducing hospital stays, disabilities associated with chronic wounds, and complications such as skin-related septicemia. Research efforts may focus on the use of growth factors, for example, for old or stubborn forms of the disease, despite proper medical treatment, or on any other innovative technique.

The properties of cold plasma appear to be suitable for the treatment of chronic wounds, as has been demonstrated in cell models, animal models, and with argon plasma in several countries around the world on an experimental basis in humans.

The GREMI in Orléans has acquired internationally recognized expertise in the technique of cold helium plasma. The combination of this applied research laboratory and the Infectious Diseases Department of the Orléans University Hospital has led to the development of relationships that have resulted in the proposal to conduct this study, based in its first phase on the evaluation of the medical device's tolerance.

Study Overview

• Status: Recruiting
• Conditions: Wound; Chronic Ulcer
• Intervention / Treatment: Device: cold plasma treatment with helium 1min/10cm2; Device: cold plasma treatment with helium 3min/10cm2; Device: dressings impregnated with ions induced by exposure to plasma

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• France
  • Orléans, France, 45000
    • Recruiting
    • Centre Hospitalier Universitaire d'Orléans, France
    • Principal Investigator: Thierry PRAZUCK, MD
    • Contact: Thierry PRAZUCK, MD; Email: thierry.prazuck@chu-orleans.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plasma treatment with exposure 1 min/10 cm² + conventional treatment	Device: cold plasma treatment with helium 1min/10cm2; The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (1min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration. The sessions will be repeated daily for 8 days.
Experimental: Plasma treatment with exposure 3 min/10 cm² + conventional treatment	Device: cold plasma treatment with helium 3min/10cm2; The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (3min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration.
Experimental: Treatment using dressings impregnated with ions induced by exposure to plasma	Device: dressings impregnated with ions induced by exposure to plasma; The plasma will be applied using the multi-jet probe by an investigating physician over the dressing, after which the nurse will apply the dressing on the ulceration.
No Intervention: Conventional treatment with hydrocolloid dressing or adapted dressing, local care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Level of local inflammation	Everyday for 8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the size of the ulcer	Measurement of the wound area using MolecuLight for daily photographies and computer analysis of the images	Day 0, Day 2, Day 4, Day 6 and Day 7
Change in the extent of tissue loss	Measuring wound volume with the MolecuLight	Day 0, Day 2, Day 4, Day 6 and Day 7
semi-quantitative change in total bacterial load	semi-quantitative change in total bacterial load between Day 0 and Day 7 on bacterial samples taken from the base of the ulcer	Day 0 and day 7

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CHUO-2024-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No