WoundPLASMA-SAFENCT07564739
Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds
A study testing cold plasma treatment with helium 1min/10cm2, cold plasma treatment with helium 3min/10cm2 and dressings impregnated with ions induced by exposure to plasma in people with Wound and Chronic Ulcer, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Chronic wounds affect many patients, with no downward trend in recent decades. This is a significant economic and social issue, and this condition has an impact on functional disabilities and quality of life, especially among the elderly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Chronic Ulcer
- What is being tested?
- cold plasma treatment with helium 1min/10cm2, cold plasma treatment with helium 3min/10cm2 and dressings impregnated with ions induced by exposure to plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2026to Sep 2027
- 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
- Men or women.
- Aged 18 years or older.
- Chronic wound or ulceration.
- Wound measuring 5 to 100 cm² of arterial or venous origin.
- Evolution > 4 weeks.
- With less than 30% necrosis.
- Able to give informed written consent.
- Blood pregnancy test for women of childbearing age.
Who cannot join
- Tumor wounds
- Dialysis
- Patients requiring surgical revascularization
- Severe heart failure (NYHA III-IV) or acute myocardial infarction.
- Wounds or ulcers located less than 10 cm from the patient's airways and respiratory tract
- Severe renal failure defined as creatinine clearance <20 mL/min calculated according to the MDRD
Show all 19Show fewer
- Patients with severe hepatic impairment (class C) according to the Child Pugh score
- Unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormality.
- Active malignant tumor
- Patients who, in the investigator's opinion, are at significant risk of suicide
- Any pre-existing physical or mental condition that may interfere with the patient's ability to comply with the administration schedule and/or protocol assessments, or that may compromise the patient's safety.
- Persons covered by Articles L.1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (including minors and protected adults)
- Protected person (under guardianship or curatorship)
- Person under judicial protection
- Persons deprived of their liberty
- Persons not affiliated with a social security system
- Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study.
- Patients participating in another clinical trial evaluating a treatment
- Allergy to the dressings used in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Orléans, France
Orléans, 45000
Thierry PRAZUCK, MD, thierry.prazuck@chu-orleans.fr
Thierry PRAZUCK, MD
About this study
Chronic wounds affect many patients, with no downward trend in recent decades. This is a significant economic and social issue, and this condition has an impact on functional disabilities and quality of life, especially among the elderly. Diagnosis is essentially clinical, and there are many causes, but 90% of leg ulcers, for example, are primarily vascular in origin. There are wounds of traumatic, post-operative, and vascular origin, as well as pressure sores. The main purpose of invasive tests is to objectively determine the cause (arterial damage) or to check for underlying osteitis. Chronic wounds are usually infected or colonized by bacteria from the skin and digestive flora. There is no indication for antibiotic therapy in the treatment of wounds. Nursing staff play an important role in therapeutic management, which must be carried out in harmony with other healthcare professionals, such as general practitioners and specialists. This management has two main goals: to accelerate the epidermalization of chronic wounds, or even their healing, and to limit local and general complications, the recurrence of which remains the most difficult to control. There are many types of healing dressings available, adapted to each type of ulceration: fibrinous, necrotic, superinfected, etc.
Nevertheless, innovative solutions can accelerate healing, thereby reducing hospital stays, disabilities associated with chronic wounds, and complications such as skin-related septicemia. Research efforts may focus on the use of growth factors, for example, for old or stubborn forms of the disease, despite proper medical treatment, or on any other innovative technique.
Read more
The properties of cold plasma appear to be suitable for the treatment of chronic wounds, as has been demonstrated in cell models, animal models, and with argon plasma in several countries around the world on an experimental basis in humans.
The GREMI in Orléans has acquired internationally recognized expertise in the technique of cold helium plasma. The combination of this applied research laboratory and the Infectious Diseases Department of the Orléans University Hospital has led to the development of relationships that have resulted in the proposal to conduct this study, based in its first phase on the evaluation of the medical device's tolerance.
- Conditions
- Wound, Chronic Ulcer
- Being tested
- cold plasma treatment with helium 1min/10cm2, cold plasma treatment with helium 3min/10cm2, dressings impregnated with ions induced by exposure to plasma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold plasma treatment with helium 1min/10cm2Device
The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (1min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration.
The sessions will be repeated daily for 8 days.
cold plasma treatment with helium 3min/10cm2Device
The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (3min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration.
dressings impregnated with ions induced by exposure to plasmaDevice
The plasma will be applied using the multi-jet probe by an investigating physician over the dressing, after which the nurse will apply the dressing on the ulceration.
| Study group | Role | What they receive |
|---|---|---|
| Plasma treatment with exposure 1 min/10 cm² + conventional treatment | Experimental | Not described Receives: Device: cold plasma treatment with helium 1min/10cm2 |
| Plasma treatment with exposure 3 min/10 cm² + conventional treatment | Experimental | Not described Receives: Device: cold plasma treatment with helium 3min/10cm2 |
| Treatment using dressings impregnated with ions induced by exposure to plasma | Experimental | Not described Receives: Device: dressings impregnated with ions induced by exposure to plasma |
| Conventional treatment with hydrocolloid dressing or adapted dressing, local care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of local inflammation
Measured: Everyday for 8 days
Secondary outcomes (3)
Change in the size of the ulcer
Measurement of the wound area using MolecuLight for daily photographies and computer analysis of the images
Measured: Day 0, Day 2, Day 4, Day 6 and Day 7
Change in the extent of tissue loss
Measuring wound volume with the MolecuLight
Measured: Day 0, Day 2, Day 4, Day 6 and Day 7
semi-quantitative change in total bacterial load
semi-quantitative change in total bacterial load between Day 0 and Day 7 on bacterial samples taken from the base of the ulcer
Measured: Day 0 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start12 May 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564739
- Sponsor's protocol ID
- CHUO-2024-03
- Acronym
- PLASMA-SAFE
- Status last verified
- May 2026
- First submitted
- 24 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds
- ClinicalTrials.gov ID
- NCT07564739
- Acronym / sponsor ID
- PLASMA-SAFE / CHUO-2024-03
- Conditions
- Wound, Chronic Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 May 2026 (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.
Chronic wounds affect many patients, with no downward trend in recent decades. This is a significant economic and social issue, and this condition has an impact on functional disabilities and quality of life, especially among the elderly. Diagnosis is essentially clinical, and there are many causes, but 90% of leg ulcers, for example, are primarily vascular in origin. There are wounds of traumatic, post-operative, and vascular origin, as well as pressure sores. The main purpose of invasive tests is to objectively determine the cause (arterial damage) or to check for underlying osteitis. Chronic wounds are usually infected or colonized by bacteria from the skin and digestive flora. There is no indication for antibiotic therapy in the treatment of wounds. Nursing staff play an important role in therapeutic management, which must be carried out in harmony with other healthcare professionals, such as general practitioners and specialists. This management has two main goals: to accelerate the epidermalization of chronic wounds, or even their healing, and to limit local and general complications, the recurrence of which remains the most difficult to control. There are many types of healing dressings available, adapted to each type of ulceration: fibrinous, necrotic, superinfected, etc.
Nevertheless, innovative solutions can accelerate healing, thereby reducing hospital stays, disabilities associated with chronic wounds, and complications such as skin-related septicemia. Research efforts may focus on the use of growth factors, for example, for old or stubborn forms of the disease, despite proper medical treatment, or on any other innovative technique.
The properties of cold plasma appear to be suitable for the treatment of chronic wounds, as has been demonstrated in cell models, animal models, and with argon plasma in several countries around the world on an experimental basis in humans.
The GREMI in Orléans has acquired internationally recognized expertise in the technique of cold helium plasma. The combination of this applied research laboratory and the Infectious Diseases Department of the Orléans University Hospital has led to the development of relationships that have resulted in the proposal to conduct this study, based in its first phase on the evaluation of the medical device's tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plasma treatment with exposure 1 min/10 cm² + conventional treatment | Experimental | Device: cold plasma treatment with helium 1min/10cm2 |
| Plasma treatment with exposure 3 min/10 cm² + conventional treatment | Experimental | Device: cold plasma treatment with helium 3min/10cm2 |
| Treatment using dressings impregnated with ions induced by exposure to plasma | Experimental | Device: dressings impregnated with ions induced by exposure to plasma |
| Conventional treatment with hydrocolloid dressing or adapted dressing, local care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women.
- Aged 18 years or older.
- Chronic wound or ulceration.
- Wound measuring 5 to 100 cm² of arterial or venous origin.
- Evolution > 4 weeks.
Key exclusion criteria (19 listed)
- Tumor wounds
- Dialysis
- Patients requiring surgical revascularization
- Severe heart failure (NYHA III-IV) or acute myocardial infarction.
- Wounds or ulcers located less than 10 cm from the patient's airways and respiratory tract
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 plasma treatment with helium 1min/10cm2The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (1min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration. The sessions will be repeated daily for 8 days. | Device | Plasma treatment with exposure 1 min/10 cm² + conventional treatment |
| cold plasma treatment with helium 3min/10cm2The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (3min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration. | Device | Plasma treatment with exposure 3 min/10 cm² + conventional treatment |
| dressings impregnated with ions induced by exposure to plasmaThe plasma will be applied using the multi-jet probe by an investigating physician over the dressing, after which the nurse will apply the dressing on the ulceration. | Device | Treatment using dressings impregnated with ions induced by exposure to plasma |
Primary outcome
Level of local inflammation
Time frame: Everyday for 8 days
3 secondary outcomes
Change in the size of the ulcer
Time frame: Day 0, Day 2, Day 4, Day 6 and Day 7
Change in the extent of tissue loss
Time frame: Day 0, Day 2, Day 4, Day 6 and Day 7
semi-quantitative change in total bacterial load
Time frame: Day 0 and day 7
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 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold plasma treatment with helium 1min/10cm2, cold plasma treatment with helium 3min/10cm2 and dressings impregnated with ions induced by exposure to plasma in people with Wound and Chronic Ulcer, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 8 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Thierry PRAZUCK, PH (+332 38 51 43 61, thierry.prazuck@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of local inflammation (time frame: Everyday for 8 days). 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 15 May 2026.