Not Yet RecruitingNot Applicable

Evaluation of Cold Plasma in Chronic Wound Healing

66 participantsStarted 2025-06

Plain-language summary

The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds. The main questions is the following: Does the application of cold atmospheric plasma accelerate wound healing compared to standard wound care alone? Researchers will compare standard of care plus plasma treatment with standard of care alone to see if the plasma-treated group shows faster wound healing. Participants will: * Receive either standard wound care alone or standard wound care combined with cold atmospheric plasma treatment, depending on randomization. * Attend scheduled hospital visits for wound care, treatment administration, and clinical assessments, including wound photography and quality of life questionnaires. * Be followed up at home by nurses for wound care, treatment administration and clinical assessment too. * Complete a wound-related quality of life questionnaire at baseline, at week 6, and at the end of the study.

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: * Adult patient, age ≥ 18 years, * Patients affiliated with a social security system or benefiting from such a system, * Patients able and willing to provide written informed consent, * Patients able and willing to attend regular follow-up visits during up to 20 weeks, and comply with study procedures, * Patients whose home healthcare professional is willing to follow the clinical investigation protocol, * Patient with gas conformed stockage area (ventilated or at least 7m²) * Patients without infection, or with a local controlled infection, * Patients with VLU: * Patients with wound anteriority between 1 to 12 months * Patients with VLU or mixed ulcer of predominantly venous origin (measured ankle brachial index (ABI) such as 1.3 ≥ ABI ≥ 0.8) * Patients with VLU between 4 to 30 cm² in surface area, * Patients with only one VLU, * Patients who have not shown wound healing improvement after wearing compression system for at least two weeks * Patients with DFU: * Patients with wound duration between 1 to 12 months * Patients with DFU and with measured ABI ≥ 0.8 or Toe Brachial Index (TBI) ≥ 0.7 * Patients with DFU between 1 to 30 cm² in surface area, * Patients with only one DFU, not between toes, * Patients who have not shown wound healing improvement after wearing an offloading system for at least two weeks, * Patient with PU: * Patient with wound duration between 1 to 12 months * Patient with PU stage 2 or 3 NPUAP grade, * Pa…

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

The percentage of patients with Relative Wound Area Reduction (RWAR) ≥ 50% at week 6 from baseline, compared between intervention group and control group, for each indication, measured using digital planimetry software (Pixacare, CE Marked)

Timeframe: From enrollment to week 6.

Trial details

NCT IDNCT06964048

SponsorPlasana Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01

Contact for this trial

Gwénaëlle Droguet

+336 61 64 12 48 gwenaelle.droguet@plasana-medical.com

View on ClinicalTrials.gov More Chronic Wounds trials