- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07564739
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Thierry PRAZUCK, PH
- Numero di telefono: +332 38 51 43 61
- Email: thierry.prazuck@chu-orleans.fr
Luoghi di studio
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Orléans, Francia, 45000
- Reclutamento
- Centre Hospitalier Universitaire d'Orléans, France
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Investigatore principale:
- Thierry PRAZUCK, MD
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Contatto:
- Thierry PRAZUCK, MD
- Email: thierry.prazuck@chu-orleans.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Persons not affiliated with a social security system
- Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study.
- Patients participating in another clinical trial evaluating a treatment
- Allergy to the dressings used in the trial
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Plasma treatment with exposure 1 min/10 cm² + conventional treatment
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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. |
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Sperimentale: Plasma treatment with exposure 3 min/10 cm² + conventional treatment
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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.
|
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Sperimentale: Treatment using dressings impregnated with ions induced by exposure to plasma
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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.
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Nessun intervento: Conventional treatment with hydrocolloid dressing or adapted dressing, local care
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Level of local inflammation
Lasso di tempo: Everyday for 8 days
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Everyday for 8 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in the size of the ulcer
Lasso di tempo: Day 0, Day 2, Day 4, Day 6 and Day 7
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Measurement of the wound area using MolecuLight for daily photographies and computer analysis of the images
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Day 0, Day 2, Day 4, Day 6 and Day 7
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Change in the extent of tissue loss
Lasso di tempo: Day 0, Day 2, Day 4, Day 6 and Day 7
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Measuring wound volume with the MolecuLight
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Day 0, Day 2, Day 4, Day 6 and Day 7
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semi-quantitative change in total bacterial load
Lasso di tempo: Day 0 and day 7
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semi-quantitative change in total bacterial load between Day 0 and Day 7 on bacterial samples taken from the base of the ulcer
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Day 0 and day 7
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHUO-2024-03
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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