Plasma On Chronic Wounds for Epidermal Regeneration (NCT05855499) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Plasma On Chronic Wounds for Epidermal Regeneration
Germany120 participantsStarted 2021-10-01
Plain-language summary
Every year, 5 million people throughout Germany suffer from extensive, often chronic wounds. Cold plasma is an innovative therapeutic approach in the treatment of these persistent tissue defects. However, previous therapy options with cold plasma are very time-consuming, especially with increasing wound area, and are also strongly dependent on the skill of the practitioner.
This study investigates the effectiveness of a system for reproducible application of cold plasma on larger areas and observes the effect of a 4-week additional plasma treatment on wound healing of large chronic wounds. The patient-related benefit of such an additional treatment will also be evaluated. Both study arms will receive guideline-based wound therapy, which is the current gold standard.
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:
Inclusion criteria are divided into patient-specific and wound-specific criteria.
Patient Criteria:
* Patient must be at least 18 years old (legal age) and legally competent
* The patient has at least one diagnosed chronic (existing for at least 8 weeks), non-healing wound due to a UCA or UCV on the lower leg, below the knee
* There is a signed consent form dated by the patient's own hand
Wound Criteria:
* In case of multiple wounds, the largest wound by area will be included in the study if it meets all inclusion criteria and no exclusion criteria and is suitable for use of the investigational product. The target wound is at least 2 cm away from the other wound(s)
* The wound was diagnosed - at the time of planned inclusion - more than 8 weeks ago and classified as a chronic wound
* The initial wound area is 5 cm²-100 cm2
* The wound can be enclosed completely by the plasma applicator (10 cm x 10 cm)
* The wound is not undermined
* The wound is located on the lower leg
Exclusion Criteria:
The exclusion criteria are divided into patient-specific and wound-specific criteria.
Patient Criteria:
* The patient is younger than 18 years and/or lacks legal capacity
* The patient has already participated in this study
* The patient is already participating in another interventional study
* Pregnant or breastfeeding patients
* The patient has an implanted pacemaker, defibrillator or other active implants
* The patient has a light/sun allergy
* The patient h…
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
Reduction in area of chronic wounds
Timeframe: 3 visits weekly for 4 weeks, follow-up at at 12 and 20 weeks