Chronic WoundsPLASANAGENESISNCT06964048
Evaluation of Cold Plasma in Chronic Wound Healing
A study testing Cold Atmospheric Plasma treatment in people with Chronic Wounds and Venous Leg Ulcer (VLU), run by Plasana Medical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds, Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU)
- What is being tested?
- Cold Atmospheric Plasma treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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,
- Patient with PU and with ABPI ≥ 0.8 and ≤ 1.3 and/or Toe Brachial Index (TBI) ≥ 0.7 if PU on the foot
- Patient with PU between 4 to 30 cm² in surface area,
- Patient with only one PU
- Patient able and willing to wear off loading system or to be install on pressure relieving system et changing position regularly,
Who cannot join
- Patients with any other wound treatments other than SOC, Patients who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) since less than three months, except for VLU patients who have undergone local graft surgery included in VLU SOC.
- Patients with an active Charcot's neuro-arthropathy as determined by clinical and/or radiographic examination,
- Patients with critical limb ischemia or severe PAD (ankle pressure < 50 mmHg or Toe pressure < 30 mmHg).
- Patients with conditions that may affect wound healing, such as rheumatoid arthritis, scleroderma, or tumor wounds.
- Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant,
- Patients with non-controlled systemic infection by a suitable antibiotic,
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- Patients with suspicion of severe malnutrition,
- Pregnancy or breastfeeding woman, or susceptible to be pregnant,
- Patients with known allergy or hypersensitivity to components of the cold plasma device or standard wound care products,
- Patients included in another study,
- Patients under guardianship or protection of vulnerable adult.
- Patients with implantable electro-medical devices.
- Patients with a history of hypersensitivity or known allergy to medical argon or any component of the device.
- Infected wounds requiring urgent medical or surgical treatment before the application of any device.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Cold Plasma in Wound Healing: A Randomized Controlled Pilot Study on Chronic Venous Leg Ulcers and Diabetic Foot Ulcers.
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.
Read more
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.
Read the detailed description
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:
- One group will receive standard wound care as per clinical practice.
- 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.
- Being tested
- Cold Atmospheric Plasma treatment
- Keywords
- Chronic wounds, Venous Leg Ulcer, VLU, Diabetic Foot Ulcer, DFU, Pressure Ulcer, PU, Cold Atmospheric Plasma, CAP, Plasma, Cold Plasma, Healing, Wound Closure
- Medical subject headings
- Varicose Ulcer, Diabetic Foot, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Atmospheric Plasma treatmentDevice
Also called CAP treatment, Plasma treatment, Plasma application, CAP application
Participants in the intervention group will be treated with cold plasma therapy with Plasana One®, as an add-on to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Participants in the control group will receive the standard of care alone. |
| Intervention Arm | Experimental | 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. Receives: Device: Cold Atmospheric Plasma treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to week 6.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: From baseline to week 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study startJun 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plasana Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dured Dardari, MD, PhD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964048
- Sponsor's protocol ID
- IC202401
- Acronym
- PLASANAGENESIS
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cold Plasma in Wound Healing: A Randomized Controlled Pilot Study on Chronic Venous Leg Ulcers and Diabetic Foot Ulcers.
- ClinicalTrials.gov ID
- NCT06964048
- Acronym / sponsor ID
- PLASANAGENESIS / IC202401
- Keywords
- Chronic wounds, Venous Leg Ulcer, VLU, Diabetic Foot Ulcer, DFU, Pressure Ulcer, PU, Cold Atmospheric Plasma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Plasana MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- One group will receive standard wound care as per clinical practice.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Participants in the control group will receive the standard of care alone. |
| Intervention Arm | Experimental | Device: Cold Atmospheric Plasma treatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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,
Key exclusion criteria (14 listed)
- Patients with any other wound treatments other than SOC, Patients who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) since less than three months, except for VLU patients who have undergone local graft surgery included in VLU SOC.
- Patients with an active Charcot's neuro-arthropathy as determined by clinical and/or radiographic examination,
- Patients with critical limb ischemia or severe PAD (ankle pressure < 50 mmHg or Toe pressure < 30 mmHg).
- Patients with conditions that may affect wound healing, such as rheumatoid arthritis, scleroderma, or tumor wounds.
- Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Atmospheric Plasma treatmentAlso: CAP treatment, Plasma treatment, Plasma application, CAP applicationParticipants in the intervention group will be treated with cold plasma therapy with Plasana One®, as an add-on to the standard of care. | Device | Intervention Arm |
Primary outcome
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)
Time frame: From enrollment to week 6.
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.
5 secondary outcomes
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)
Time frame: Each week from baseline to week 20.
Time to 100% re-epithelialization in the two patient groups
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dured Dardari, MD, PhD principal investigator
Centre Hospitalier Sud Francilien
Questions about this trial
What is this clinical trial studying?
A study testing Cold Atmospheric Plasma treatment in people with Chronic Wounds and Venous Leg Ulcer (VLU), run by Plasana Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gwénaëlle Droguet (+336 61 64 12 48, gwenaelle.droguet@plasana-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: From enrollment to week 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.