Clinical Trial

Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing

Study acronym: PLASFRI-CUV
Active, Not Recruiting
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Summary
In this medical trial, a novel prototype of a medical device based on a Cold Atmospheric Air Plasma Jet for the treatment is clinically tested on patients with venous leg ulcers. The device is characterized by producing the first cold air plasma jet compatible with living tissues at a low heat transfer rate with a temperature on the skin surface lower than 40 ºC. It has a practical design to be used by physicians during daily practice with a special focus on unhealed ulcers.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-05-30; most recent amendment 2025-01-02.
Status change: Recruiting → Active, Not Recruiting 2025-01-02
Trial Details
NCT Number NCT05894096
Lead Sponsor Clinica Universidad de Navarra, Universidad de Navarra
Collaborators: Hospital General Universitario Gregorio Marañon, Complejo Hospitalario La Mancha Centro, FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Conditions Venous Leg Ulcer
Enrollment 68 participants
Start Date 2023-03-24
Primary Completion 2024-06-21 (estimated)
Study Completion 2025-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-01-03