Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing (NCT05894096) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing
Spain68 participantsStarted 2023-03-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Ulcer Surface
Timeframe: 18 weeks
Trial details
NCT IDNCT05894096
SponsorClinica Universidad de Navarra, Universidad de Navarra