Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds

NCT07564739 | Not Yet Recruiting

• 1 other identifier: CHUO-2024-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound; Chronic Ulcer

Outcome Measures

Primary Outcomes (1)

• Level of local inflammation

  Everyday for 8 days

Secondary Outcomes (3)

• Change in the size of the ulcer

  Day 0, Day 2, Day 4, Day 6 and Day 7

• Change in the extent of tissue loss

  Day 0, Day 2, Day 4, Day 6 and Day 7

• semi-quantitative change in total bacterial load

  Day 0 and day 7

Study Arms (4)

Plasma treatment with exposure 1 min/10 cm² + conventional treatment

EXPERIMENTAL

Device: cold plasma treatment with helium

Plasma treatment with exposure 3 min/10 cm² + conventional treatment

EXPERIMENTAL

Device: cold plasma treatment with helium

Treatment using dressings impregnated with ions induced by exposure to plasma

EXPERIMENTAL

Device: cold plasma treatment with helium

Conventional treatment with hydrocolloid dressing or adapted dressing, local care

NO INTERVENTION

Interventions

cold plasma treatment with helium DEVICE

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, 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.

Plasma treatment with exposure 1 min/10 cm² + conventional treatment; Plasma treatment with exposure 3 min/10 cm² + conventional treatment; Treatment using dressings impregnated with ions induced by exposure to plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women.
• Aged 18 years or older.
• Chronic wound or ulceration.
• Wound measuring 5 to 100 cm² of arterial or venous origin.
• Evolution \> 4 weeks.
• With less than 30% necrosis.
• Able to give informed written consent.
• Blood pregnancy test for women of childbearing age.

You may not qualify if:

• Tumor wounds
• Dialysis
• Patients requiring surgical revascularization
• Severe heart failure (NYHA III-IV) or acute myocardial infarction.
• Wounds or ulcers located less than 10 cm from the patient's airways and respiratory tract
• Severe renal failure defined as creatinine clearance \<20 mL/min calculated according to the MDRD
• Patients with severe hepatic impairment (class C) according to the Child Pugh score
• Unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormality.
• Active malignant tumor
• Patients who, in the investigator's opinion, are at significant risk of suicide
• 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.
• 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)
• Protected person (under guardianship or curatorship)
• Person under judicial protection
• Persons deprived of their liberty

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Orléans, France

Orléans, 45000, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Thierry PRAZUCK, PH

CONTACT

+332 38 51 43 61; thierry.prazuck@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: May 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)