Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing
NCT ID: NCT05894096
Last Updated: 2025-01-03
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
68 participants
INTERVENTIONAL
2023-03-24
2025-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
SINGLE
Study Groups
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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.
Cold Atmospheric Plasma Jet Treatment
Application of Colf Atmospheric Plasma Jet on the wound
Alginate Patch
Application of Alginate Patches on the wound
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.
Alginate Patch
Application of Alginate Patches on the wound
Interventions
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Cold Atmospheric Plasma Jet Treatment
Application of Colf Atmospheric Plasma Jet on the wound
Alginate Patch
Application of Alginate Patches on the wound
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hospital General Universitario Gregorio Marañon
OTHER
Complejo Hospitalario La Mancha Centro
OTHER
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
OTHER
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Principal Investigators
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Bernardo C Hontanilla, Ph.D.
Role: STUDY_DIRECTOR
Clínica Universidad de Navarra
José M Lasso Vázquez, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañón
Jesús J Castellanos Monedero, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital General la Mancha-Centro
Javier Buendía Pérez, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital San Carlos, Madrid
José I Leal Lorenzo, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Clínica Universidad de Navarra
Locations
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Hospital General La Mancha Centro
Alcázar de San Juan, Ciudad Real, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Clinica Universidad de Navarra
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Countries
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References
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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.
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.
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.
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.
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.
MORFILL G. TREATING DEVICE FOR TREATING A BODY PART OF A PATIENT WITH A NON-THERMAL PLASMA. WO 2010/094307 Al, 2009.
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.
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.
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.
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.
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.
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
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.
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.
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.
Other Identifiers
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PLASFRI-CUV
Identifier Type: -
Identifier Source: org_study_id
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