Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo (NCT07050667) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo
Austria70 participantsStarted 2023-05-01
Plain-language summary
Objective: The study aimed to evaluate the wound healing effects of plasma care®, a cold atmospheric plasma device, in patients with chronic wounds.
Method: A prospective, multicenter, two-arm, randomized, single-blind clinical trial was conducted to compare the effectiveness of plasma care® versus placebo, both combined with best practice wound care.
Who can participate
Age range
18 Years – 95 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:
* Age between 18 and 95 years at the time of consent
* Presence of chronic wounds of any origin and wound phase (Includes locally infected wounds)
* Wound size up to 20 x 10 cm (If multiple wounds are present, one wound is designated as the study wound)
Exclusion Criteria:
* Pregnant and breastfeeding women
* Patients on ongoing systemic antibiotic therapy or who received antibiotics within 1 week prior to study start
* Patients who participated in another study within one month prior to this study
* Patients with acute wounds
* Wounds with visible tendons and bones
* Wounds with more than 30% dry necrosis
* Allergy or intolerance to cold plasma
* Patients with wounds covered by primary or secondary dressings
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
Wound area at the end of the study
Timeframe: 42 days
2
Size and time course of the wound area at the end of the study
Timeframe: 42 days
3
Percentage change in wound area at the end of the study
Timeframe: 42 days
4
Dynamics of the percentage change in wound area from baseline