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

NCT05894096 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-01-03

No results posted yet for this study

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.

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Cold Atmospheric Plasma Jet Treatment

Application of Colf Atmospheric Plasma Jet on the wound

DEVICE

Alginate Patch

Application of Alginate Patches on the wound

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Complejo Hospitalario La Mancha Centro

    collaborator OTHER

  • FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS

    collaborator OTHER

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Bernardo C Hontanilla, Ph.D. · Clínica Universidad de Navarra

  • José M Lasso Vázquez, Ph.D. · Hospital General Universitario Gregorio Marañón

  • Jesús J Castellanos Monedero, M.D. · Hospital General la Mancha-Centro

  • Javier Buendía Pérez, Ph.D. · Hospital San Carlos, Madrid

  • José I Leal Lorenzo, Ph.D. · Clínica Universidad de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2024-06-21
Completion
2025-03-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894096 on ClinicalTrials.gov