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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ulcer Surface
Timeframe: 18 weeks
Trial details
NCT IDNCT05894096
SponsorClinica Universidad de Navarra, Universidad de Navarra