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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Centre Hospitalier Universitaire d'Orléans, France
RECRUITING
Orléans
Contact Information
Primary
Thierry PRAZUCK, PH
thierry.prazuck@chu-orleans.fr
+332 38 51 43 61
Time Frame
Start Date: 2026-05-12
Estimated Completion Date: 2027-09
Participants
Target number of participants: 40
Treatments
Experimental: Plasma treatment with exposure 1 min/10 cm² + conventional treatment
Experimental: Plasma treatment with exposure 3 min/10 cm² + conventional treatment
Experimental: Treatment using dressings impregnated with ions induced by exposure to plasma
No_intervention: Conventional treatment with hydrocolloid dressing or adapted dressing, local care
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Régional d'Orléans

This content was sourced from clinicaltrials.gov