Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

12 de mayo de 2026 actualizado por: Centre Hospitalier Régional d'Orléans

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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Orléans, Francia, 45000
        • Reclutamiento
        • Centre Hospitalier Universitaire d'Orléans, France
        • Investigador principal:
          • Thierry PRAZUCK, MD
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Plasma treatment with exposure 1 min/10 cm² + conventional treatment

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
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
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.
Sin intervención: Conventional treatment with hydrocolloid dressing or adapted dressing, local care

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Level of local inflammation
Periodo de tiempo: Everyday for 8 days
Everyday for 8 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the size of the ulcer
Periodo de tiempo: Day 0, Day 2, Day 4, Day 6 and Day 7
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
Periodo de tiempo: Day 0, Day 2, Day 4, Day 6 and Day 7
Measuring wound volume with the MolecuLight
Day 0, Day 2, Day 4, Day 6 and Day 7
semi-quantitative change in total bacterial load
Periodo de tiempo: Day 0 and day 7
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de mayo de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2026

Publicado por primera vez (Actual)

4 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CHUO-2024-03

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir