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

NCT05894096 | Active Not Recruiting

• 1 other identifier: PLASFRI-CUV
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 5

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.

Conditions

Venous Leg Ulcer

Keywords

Cold atmospheric plasma; venous ulcer; wound healing

Outcome Measures

Primary Outcomes (1)

• Ulcer Surface

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

  18 weeks

Secondary Outcomes (1)

• Measurement of bacterial burden

  18 weeks

Study Arms (2)

Cold Athmospheric Plasma Jet+Alginate patch

EXPERIMENTAL

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; Device: Alginate Patch

Alginate patch

ACTIVE COMPARATOR

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

Interventions

Cold Atmospheric Plasma Jet Treatment DEVICE

Application of Colf Atmospheric Plasma Jet on the wound

Cold Athmospheric Plasma Jet+Alginate patch

Alginate Patch DEVICE

Application of Alginate Patches on the wound

Alginate patch; Cold Athmospheric Plasma Jet+Alginate patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Hospital General Universitario Gregorio Marañon: collaborator
• Complejo Hospitalario La Mancha Centro: collaborator
• FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS: collaborator

Study Sites (5)

Hospital General La Mancha Centro

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Clinica Universidad de Navarra

Madrid, Madrid, 28027, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (15)

• Kisch T, Schleusser S, Helmke A, Mauss KL, Wenzel ET, Hasemann B, Mailaender P, Kraemer R. The repetitive use of non-thermal dielectric barrier discharge plasma boosts cutaneous microcirculatory effects. Microvasc Res. 2016 Jul;106:8-13. doi: 10.1016/j.mvr.2016.02.008. Epub 2016 Mar 2.

  PMID: 26944583 BACKGROUND

• Kisch T, Helmke A, Schleusser S, Song J, Liodaki E, Stang FH, Mailaender P, Kraemer R. Improvement of cutaneous microcirculation by cold atmospheric plasma (CAP): Results of a controlled, prospective cohort study. Microvasc Res. 2016 Mar;104:55-62. doi: 10.1016/j.mvr.2015.12.002. Epub 2015 Dec 3.

  PMID: 26655582 BACKGROUND

• Jensen JO, Schulz L, Schleusser S, Matzkeit N, Stang FH, Mailaender P, Kraemer R, Kleemann M, Deichmann H, Kisch T. The repetitive application of cold atmospheric plasma (CAP) improves microcirculation parameters in chronic wounds. Microvasc Res. 2021 Nov;138:104220. doi: 10.1016/j.mvr.2021.104220. Epub 2021 Jun 30.

  PMID: 34216601 BACKGROUND

• Matzkeit N, Schulz L, Schleusser S, Jensen JO, Stang FH, Mailaender P, Kramer R, Kisch T. Cold atmospheric plasma improves cutaneous microcirculation in standardized acute wounds: Results of a controlled, prospective cohort study. Microvasc Res. 2021 Nov;138:104211. doi: 10.1016/j.mvr.2021.104211. Epub 2021 Jun 16.

  PMID: 34144075 BACKGROUND

• Heuer K, Hoffmanns MA, Demir E, Baldus S, Volkmar CM, Rohle M, Fuchs PC, Awakowicz P, Suschek CV, Oplander C. The topical use of non-thermal dielectric barrier discharge (DBD): nitric oxide related effects on human skin. Nitric Oxide. 2015 Jan 30;44:52-60. doi: 10.1016/j.niox.2014.11.015. Epub 2014 Nov 27.

  PMID: 25435001 BACKGROUND

• MORFILL G. TREATING DEVICE FOR TREATING A BODY PART OF A PATIENT WITH A NON-THERMAL PLASMA. WO 2010/094307 Al, 2009.

  BACKGROUND

• Ziuzina D, Boehm D, Patil S, Cullen PJ, Bourke P. Cold Plasma Inactivation of Bacterial Biofilms and Reduction of Quorum Sensing Regulated Virulence Factors. PLoS One. 2015 Sep 21;10(9):e0138209. doi: 10.1371/journal.pone.0138209. eCollection 2015.

  PMID: 26390435 BACKGROUND

• Cooper M, Fridman G, Fridman A, Joshi SG. Biological responses of Bacillus stratosphericus to floating electrode-dielectric barrier discharge plasma treatment. J Appl Microbiol. 2010 Dec;109(6):2039-48. doi: 10.1111/j.1365-2672.2010.04834.x.

  PMID: 20825520 BACKGROUND

• CORTÁZAR PÉREZ OD, MEGIA MACÍAS AM. Electromedical device for blood clotting and treatment of ulcers and other skin injuries in human and animal patients. 2020.

  BACKGROUND

• Ulrich C, Kluschke F, Patzelt A, Vandersee S, Czaika VA, Richter H, Bob A, Hutten Jv, Painsi C, Huge R, Kramer A, Assadian O, Lademann J, Lange-Asschenfeldt B. Clinical use of cold atmospheric pressure argon plasma in chronic leg ulcers: A pilot study. J Wound Care. 2015 May;24(5):196, 198-200, 202-3. doi: 10.12968/jowc.2015.24.5.196.

  PMID: 25970756 BACKGROUND

• Chuangsuwanich A, Assadamongkol T, Boonyawan D. The Healing Effect of Low-Temperature Atmospheric-Pressure Plasma in Pressure Ulcer: A Randomized Controlled Trial. Int J Low Extrem Wounds. 2016 Dec;15(4):313-319. doi: 10.1177/1534734616665046. Epub 2016 Sep 20.

  PMID: 27581113 BACKGROUND

• A. Nishijima. A New Energy Device for Skin Activation to Acute Wound Using Cold Atmospheric Pressure Plasma: A Randomized Controlled Clinical Trial. Biomed J Sci Tech Res. 2019;21(1):15494-501. DOI: 10.26717/BJSTR.2019.21.003532

  BACKGROUND

• Amini MR, Sheikh Hosseini M, Fatollah S, Mirpour S, Ghoranneviss M, Larijani B, Mohajeri-Tehrani MR, Khorramizadeh MR. Beneficial effects of cold atmospheric plasma on inflammatory phase of diabetic foot ulcers; a randomized clinical trial. J Diabetes Metab Disord. 2020 Jul 14;19(2):895-905. doi: 10.1007/s40200-020-00577-2. eCollection 2020 Dec.

  PMID: 33520811 BACKGROUND

• Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Gorlitz A, Simon D, Schon MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm((R)) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622). J Eur Acad Dermatol Venereol. 2015 Jan;29(1):148-55. doi: 10.1111/jdv.12490. Epub 2014 Mar 25.

  PMID: 24666170 BACKGROUND

• Brany D, Dvorska D, Halasova E, Skovierova H. Cold Atmospheric Plasma: A Powerful Tool for Modern Medicine. Int J Mol Sci. 2020 Apr 22;21(8):2932. doi: 10.3390/ijms21082932.

  PMID: 32331263 BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bernardo C Hontanilla, Ph.D.

  Clínica Universidad de Navarra

  STUDY DIRECTOR

• José M Lasso Vázquez, Ph.D.

  Hospital General Universitario Gregorio Marañón

  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.

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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.

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 8, 2023
• Study Start: March 24, 2023
• Primary Completion: June 21, 2024
• Study Completion: March 30, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available in 2025 and will be availabe for 10 years

Locations

ES (5)