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

Venous Leg Ulcer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

• NCT number: NCT05894096
• Study type: Interventional
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: Bernardo Hontanilla, Ph.D.
• Phone: +34 948 255 400
• Email: bhontanill@unav.es
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2023
• Completion date: June 30, 2024