An interventional study of Cold Atmospheric Plasma treatment in Chronic Wounds, Venous Leg Ulcer (VLU) and Diabetic Foot Ulcer (DFU), sponsored by Plasana Medical. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Plasana Medical · Not applicable, Interventional, and Treatment
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:
This is a multicenter, randomized, controlled clinical trial evaluating the efficacy and safety of cold atmospheric plasma (CAP) therapy using the Plasana One® device in the treatment of chronic wounds. The study aims to compare the outcomes of standard of care alone versus standard of care combined with plasma treatment.
60 eligible participants presenting with chronic wounds (such as venous leg ulcers or diabetic foot ulcers) will be randomized into two groups:
The other group will receive standard wound care along with cold plasma therapy administered using the Plasana One® device.
6 participants suffering from pressure ulcers will also be included for an ancillary study.
The study includes both hospital-based and home-based components. Key study procedures include wound assessment through photography, clinical data collection using an electronic case report form (eCRF), and evaluation of patient-reported outcomes such as quality of life (Wound-QoL questionnaire).
Treatments and follow-up visits will be conducted by hospital investigators and home healthcare professionals, depending on the participant's care pathway. Plasma treatment will be delivered by trained nurses during home visits, with gas supplies and device management coordinated by a home care service provider (PSAD).
The primary objective is to evaluate the efficacy of the cold plasma device Plasana One® in the local management of chronic wounds in participants suffering from diabetic foot ulcers and venous leg ulcers, at Week 6.
Secondary objectives include wound healing progression, quality of life, safety of plasma application, and user satisfaction over a 20-week period.
The objective of the ancillary study will be to describe the healing process in pressure ulcers.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →This is the only study on the registry with Plasana Medical as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with VLU:
Patients with DFU:
Patient with PU:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the control group will receive the standard of care alone.
Participants in the intervention group will be treated according to the same protocol as the control group, with the addition of cold plasma therapy with Plasana One®, as an add-on to the standard of care.
Device: Cold Atmospheric Plasma treatment
Participants in the intervention group will be treated with cold plasma therapy with Plasana One®, as an add-on to the standard of care.
Also known as: CAP treatment, Plasma treatment, Plasma application, CAP application, Cold plasma therapy
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)
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. With : RWAR; in % : \[(SD0 - SW6)/SD0\] x 100 SW6 : wound area at week 6 SD0 : wound area at D0 The wound area will be measured in a standardized way using digital planimetry with Pixacare software, guaranteeing a reproducible and objective measurement.
Time frame: From enrollment to week 6.
In each arm, the percentage of patients with Relative Wound Area Reduction (RWAR)≥ 50% at each week from baseline, measured using digital planimetry software (Pixacare, CE Marked)
With : RWAR; in % : \[(SD0 - SW6)/SD0\] x 100 SW6 : wound area at week 6 SD0 : wound area at D0 The wound area will be measured in a standardized way using digital planimetry with Pixacare software, guaranteeing a reproducible and objective measurement.
Time frame: Each week from baseline to week 20.
Time to 100% re-epithelialization in the two patient groups
100% re-epithelialization will be assessed by the home healthcare provider or the investigational center of the patient, and confirmed by two other blinded investigators.
Time frame: From baseline to week 20.
The percentage of wounds achieving complete closure defined by 100% re-epithelization, at W6, W12, W20, in both patient groups
100% re-epithelialization will be assessed by the home healthcare provider or the investigational center of the patient, and confirmed by two other blinded investigators.
Time frame: At week 6, at week 12 and week 20 post inclusion.
In the two patient groups, the measurement of wound surface from baseline to W6, W12, W20, measured using digital planimetry software (Pixacare, CE Marked)
Time frame: At week 6, at week 12 and week 20 post inclusion.
In each arm, the number of care procedures (SOC only or SOC + CAP) will be compared between the distinct time points
Time frame: From baseline to week 20.
The occurrence and seriousness of adverse events related to the use of Plasana One®
Time frame: From baseline to week 20.
Score change from baseline based on the Wound-QOL-17 at week 6, at week 12 and week 20
Time frame: At week 6, at week 12 and week 20 post inclusion.
Treatment pain evolution based on an Visual Analog Scale
Time frame: From baseline to week 20.
Usability questionnaire completed at the end of the treatment period by the investigators and nurses, as final users of the device
Time frame: Week 20
Ancillary outcome for Pressure Ulcers patients only: In the two patient groups, the measurement of wound surface from baseline to W6, W12, W20, measured using digital planimetry software (Pixacare, CE Marked)
In each arm for PU patients, the measurement of wound surface from baseline to W6, W12, W20, measured using digital planimetry software (Pixacare, CE Marked) As for the primary endpoint, the wound area will be measured in a standardized way using Pixacare software, guaranteeing a reproducible and objective measurement.
Time frame: From baseline to week 20.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Jan 2026, 7 months later.
Of 66 industry-sponsored interventional studies with no phase under Varicose Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's planned 7 months is below that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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