Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing (PLASFRI-CUV)

January 2, 2025 updated by: Clinica Universidad de Navarra, Universidad de Navarra
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The device to be validated in this test is an air-generating unit in a cold plasma state, a prototype of a medical device. Cold plasma-generating equipment is already available on the market and is intended for the treatment of chronic ulcers in patients. Its technology is based on the generation of a plasma jet produced with the noble gas argon. The novelty of this new plasma generator lies in the fact that its production is carried out by using atmospheric air, which implies greater efficiency and ease of use, being the first of its kind at an international level. The main mechanism of action underlying the therapeutic effect of cold atmospheric plasmas is the effect of the electric fields produced by the charged particles that make up the air in the plasma state. These fields are imperceptible to the patient, however, the effect on microcirculation in the area of application of the wound is very noticeable. The improvement in microcirculation extends for a longer time than the treatment as demonstrated by reported oxygen saturation studies using cold air plasmas DBD (Dielectric Barrier Discharge) that include clinical trials (1-4). Enhanced capillary blood flow increases local oxygen saturation and nutrient supply, thus promoting wound healing (5). In addition to the action of electric fields, there is an auxiliary decontamination mechanism generated by the emission of ultraviolet radiation, below the damage threshold for humans and excited and ionized oxygen and nitrogen molecules. This mechanism eliminates bacteria, including resistant ones, so that the regeneration capacity promoted by the main mechanism of action is enhanced (6-8).

The generator chosen for this test belongs to the Spanish company ION BIOTEC S.L. (PlasmAction Med), which has obtained an international patent (9). Its use in animals has been successfully developed in veterinary clinics and the positive results obtained in the closure of torpid ulcers using cold atmospheric plasmas have been demonstrated (10-13). The plasma jet is applied directly to the lesion presented by the patient with a power of 55% and with an intensity and duration of 60 s/cm2, by means of the regulator found at the end of an application hose. It does not use consumables or produce waste.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra
    • Ciudad Real
      • Alcázar de San Juan, Ciudad Real, Spain, 13600
        • Hospital General La Mancha Centro
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be of legal age (18 years).
  • Signed informed consent.
  • Presenting at least one venous ulcer larger than 1 cm2 that has not healed in the last 3 weeks from its appearance.
  • Absence of surgical indication for ulcer coverage by skin graft.

Exclusion Criteria:

  • Uncontrolled diabetes mellitus (HbA1c > 8%). If during the trial the patient suffers a decompensation of diabetes, it will be considered an adverse event.
  • Patient allergic to silver or any other material that will be used during the cure of the ulcer under study.
  • Concomitant treatment with vacuum-assisted closure (VAC) therapy.
  • Use of topical antibiotic therapy. The minimum washing time should be 48 hours.
  • Presence of critical limb ischemia defined as an ankle-brachial index (ABI) below 0.5 or a transcutaneous O2 pressure (TcPO2) below 15 mmHg.
  • Treatment with corticosteroids in the 14 days prior to the study or with other immunosuppressants.
  • Presence of a chronic or active skin disorder that may negatively influence wound healing (such as Marfan or Ehlers-Danlos syndrome, systemic lupus erythematosus, systemic sclerosis, or psoriasis).
  • Pregnancy or lactation.
  • Advanced or metastatic stage cancer.
  • Deficiency states.
  • Dementia.
  • Post radiation wounds.
  • Sepsis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold Athmospheric Plasma Jet+Alginate patch
Leg Venous Ulcers will be treated in all patients belonging to the experimental arm using the PlasmAction Med cold plasma generator at atmospheric air pressure and alginate (Melgisorb Ag®) will be used after the plasma has been applied.
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
Active Comparator: Alginate patch
For patients included in the control arm, alginate (Melgisorb Ag®) will be used as a cure for ulcers, size 10 X 10 cm and 5x5 (3 units), whose replacements will also be carried out twice a week.
Device: Alginate Patch
Application of Alginate Patches on the wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ulcer Surface
Time Frame: 18 weeks
The surface of the ulcer will be meassured by means of sofware image J2
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of bacterial burden
Time Frame: 18 weeks
Bacteriological cultures will be taken before and after of the treated group at 0, 5 and 10 weeks. Control groups at º, 5 and 10 weeks.
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Study Director: Bernardo C Hontanilla, Ph.D., Clinica Universidad de Navarra
  • Principal Investigator: José M Lasso Vázquez, Ph.D., Hospital General Universitario Gregorio Marañon
  • Principal Investigator: Jesús J Castellanos Monedero, M.D., Hospital General la Mancha-Centro
  • Principal Investigator: Javier Buendía Pérez, Ph.D., Hospital San Carlos, Madrid
  • Principal Investigator: José I Leal Lorenzo, Ph.D., Clinica Universidad de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2023

Primary Completion (Actual)

June 21, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLASFRI-CUV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When finished the protocol the data collected will be shared with other researches in order to continue other clinical trials

IPD Sharing Time Frame

Data will be available in 2025 and will be availabe for 10 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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