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

Study acronym: PLASFRI-CUV
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv3 Show 4 more changesShow less
    • Study sites: 2 to 5
    • Primary completion date changed from estimate of Mar 24, 2024 to Jun 21, 2024
    • Study completion date: Jun 30, 2024 to Mar 30, 2025
    • Collaborators: 1 to 3
  2. Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 1 word
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Venous Leg Ulcer
Related terms Varicose Ulcer
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov