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

Primary Purpose

Venous Leg Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cold Atmospheric Plasma Jet Treatment
Alginate Patch
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring Cold atmospheric plasma, venous ulcer, wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinica Universidad de NavarraRecruiting
  • Clinica Universidad de NavarraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cold Athmospheric Plasma Jet+Alginate patch

Alginate patch

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ulcer Surface
The surface of the ulcer will be meassured by means of sofware image J2

Secondary Outcome Measures

Measurement of bacterial burden
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.

Full Information

First Posted
May 29, 2023
Last Updated
June 12, 2023
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Hospital General Universitario Gregorio Marañon
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1. Study Identification

Unique Protocol Identification Number
NCT05894096
Brief Title
Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing
Acronym
PLASFRI-CUV
Official Title
Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
March 24, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Hospital General Universitario Gregorio Marañon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
Keywords
Cold atmospheric plasma, venous ulcer, wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, open-label, controlled clinical trial with conventional treatment. Programming and continuous recruitment. The ulcers of the experimental group will be treated with 60 seconds/cm2 of the wound surface, carried out twice a week, and with alginate with silver. For their part, the ulcers in the control group will be treated with alginate with silver, which will also be replaced twice a week. The total duration of the trial for each patient will be 10 weeks (2 times per week) followed by 8 weeks of follow-up. The treatment will be carried out twice a week, maintaining at least 72 hours between treatments. The patients included in this trial will be all those who attend consultations or are hospitalized. They must present at least one venous ulcer larger than 1 cm2 that has not healed in the last 8 weeks from its onset and with no surgical indication for ulcer coverage by a skin graft.
Masking
Participant
Masking Description
Patients will be randomly distributed into two arms: Experimental and Control. Ulcers will be treated in all patients of the experimental arm using the PlasmAction Med cold plasma generator. The plasma jet will be programmed to be applied with an intensity of 55% power and with 60 seconds/cm2 of surface, the frequency being twice a week for 10 weeks. This therapeutic regimen is based on previous studies of previously published clinical trials with argon jet cold plasma (14,15). The administration of treatment will be the responsibility of the principal investigator and the collaborator with the help of the nursing staff. After the application of the plasma treatment, the patient will then be cured with alginate (Melgisorb Ag®) of the size 10 X 10 cm and 5x5 (3 units). 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.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold Athmospheric Plasma Jet+Alginate patch
Arm Type
Experimental
Arm Description
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.
Arm Title
Alginate patch
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cold Atmospheric Plasma Jet Treatment
Intervention Description
Application of Colf Atmospheric Plasma Jet on the wound
Intervention Type
Device
Intervention Name(s)
Alginate Patch
Intervention Description
Application of Alginate Patches on the wound
Primary Outcome Measure Information:
Title
Ulcer Surface
Description
The surface of the ulcer will be meassured by means of sofware image J2
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Measurement of bacterial burden
Description
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.
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernardo Hontanilla, Ph.D.
Phone
+34 948 255 400
Ext
4404
Email
bhontanill@unav.es
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Cortazar, Ph.D.
Phone
+34 652428598
Email
daniel.cortazar@medicalplasmas.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernardo Hontanilla, Ph.D.
Organizational Affiliation
Clinica Universidad de Navarra
Official's Role
Study Director
Facility Information:
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernardo Hontanilla, Ph.D.
Phone
+34 948 255 400
Email
bhontanill@unav.es
Facility Name
Clinica Universidad de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Leal, Ph.D.
Phone
+34 948 255 400
Email
atpacientecun@unav.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing

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