Hard to Heal WoundsSUPCAPNCT07050667
Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo
A study testing Cold atmospheric plasma in people with Hard to Heal Wounds and Infected Wound, run by Terraplasma Medical GmbH at 2 sites in Austria.
Trial summary
Objective: The study aimed to evaluate the wound healing effects of plasma care®, a cold atmospheric plasma device, in patients with chronic wounds. Method: A prospective, multicenter, two-arm, randomized, single-blind clinical trial was conducted to compare the effectiveness of plasma care® versus placebo, both… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hard to Heal Wounds, Infected Wound
- What is being tested?
- Cold atmospheric plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesAustria
- Study dates
- 1 May 2023to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 95 years at the time of consent
- Presence of chronic wounds of any origin and wound phase (Includes locally infected wounds)
- Wound size up to 20 x 10 cm (If multiple wounds are present, one wound is designated as the study wound)
Who cannot join
- Pregnant and breastfeeding women
- Patients on ongoing systemic antibiotic therapy or who received antibiotics within 1 week prior to study start
- Patients who participated in another study within one month prior to this study
- Patients with acute wounds
- Wounds with visible tendons and bones
- Wounds with more than 30% dry necrosis
- Allergy or intolerance to cold plasma
- Patients with wounds covered by primary or secondary dressings
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo: a Multicenter, Two-arm, Randomized, Single-blind, Prospective, Clinical Study
Objective: The study aimed to evaluate the wound healing effects of plasma care®, a cold atmospheric plasma device, in patients with chronic wounds.
Method: A prospective, multicenter, two-arm, randomized, single-blind clinical trial was conducted to compare the effectiveness of plasma care® versus placebo, both combined with best practice wound care.
Read the detailed description
Chronic wounds present a growing global health challenge, significantly affecting patients' quality of life and imposing high treatment costs. Despite advances in wound care, such as bioactive dressings and specialized medical personnel, effective treatment remains difficult due to the complexity of the wounds and underlying conditions.
Cold atmospheric plasma (CAP) has recently emerged as a promising treatment. CAP is created by ionizing gas with strong electric fields, producing reactive species that stimulate human cell regeneration while also exhibiting strong antibacterial and antifungal effects-even against antibiotic-resistant strains. This dual action makes CAP especially useful for chronic wounds, which are prone to infections.
CAP also benefits wound healing by lowering wound pH. Chronic wounds often have an alkaline environment conducive to bacterial growth, but CAP shifts the pH toward more acidic levels, supporting cell function and antibacterial activity.
Clinical studies have shown CAP significantly improves wound healing by promoting granulation tissue formation, reducing wound size and infection, and alleviating symptoms like redness and itching. CAP has also proven safe, with no mutagenic effects on healthy cells.
Different technologies exist to generate CAP, including Dielectric Barrier Discharge (DBD), Plasma Jet, and Surface Micro Discharge (SMD). The plasma care® device used in this study is based on SMD technology, allowing mobile, gas-free use to treat areas up to 13 cm², with treatment dose determined by application duration.
This study aims to evaluate whether plasma care® provides significantly better healing outcomes in chronic wounds of various types compared to placebo treatment. It also seeks to understand the impact of CAP on wound healing factors such as infection control, pH reduction, and exudate management, alongside patient experiences like pain and tolerability. If successful, this study could establish plasma care® as a valuable new option in chronic wound therapy.
- Conditions
- Hard to Heal Wounds, Infected Wound
- Being tested
- Cold atmospheric plasma, Placebo treatment
- Keywords
- placebo controlled, plasma care, non thermal plasma, cold atmospheric plasma, wound healing, chronic wounds
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold atmospheric plasmaDevice
Treatment of chronic wounds with cold plasma
Placebo treatmentDevice
Treatment of chronic wounds with the placebo device
| Study group | Role | What they receive |
|---|---|---|
| Plasma arm | Active comparator | Treatment of patients with cold atmospheric plasma Receives: Device: Cold atmospheric plasma |
| Placebo arm | Placebo comparator | Placebo control Receives: Device: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound area at the end of the study
Size of the wound area (absolute) in cm2
Measured: 42 days
Size and time course of the wound area at the end of the study
Average time course in size (absolute) of the wound area in cm2 per visit
Measured: 42 days
Percentage change in wound area at the end of the study
Wound area as a percentage (from baseline)
Measured: 42 days
Dynamics of the percentage change in wound area from baseline
Average time course of the percentage in wound area (compared to the initial value)
Measured: 42 days
Secondary outcomes (5)
pH value
pH measurement by pH meter
Measured: 42 days
Pain Score
Pain as measured by the VAS Score (1 - 10)
Measured: 42 days
Infection Score
Infection, measured by the PGA - Physician Global Assessment Score ranging from 0 (no signs of infection) to 4 (maximal signs of infection); 1-4 is considered infected
Measured: 42 days
Tolerability of treatment
no problem (e.g. no maceration, deterioration of the wound, blisters) new development/intensification of erythema (maceration, blisters, exudate congestion)
Measured: 42 days
Subjective sensation
Subjective sensation as given by the patient: 1 (pleasant feeling), 2 (no specific sensation), 3 (unpleasant), 4 (very unpleasant)
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 May 2023
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hard to Heal 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
- Model description
- prospective, multicenter, two-arm, randomized, single-blind, clinical study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terraplasma Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050667
- Sponsor's protocol ID
- EK-2-3/2023
- Other IDs
- PLASMACARE/70/Q1-23
- Acronym
- SUPCAP
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to austrian legal privacy laws
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo: a Multicenter, Two-arm, Randomized, Single-blind, Prospective, Clinical Study
- ClinicalTrials.gov ID
- NCT07050667
- Acronym / sponsor ID
- SUPCAP / EK-2-3/2023
- Conditions
- Hard to Heal Wounds, Infected Wound
- Keywords
- placebo controlled, plasma care, non thermal plasma, cold atmospheric plasma, wound healing, chronic wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Terraplasma Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 3 Jul 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.
Objective: The study aimed to evaluate the wound healing effects of plasma care®, a cold atmospheric plasma device, in patients with chronic wounds.
Method: A prospective, multicenter, two-arm, randomized, single-blind clinical trial was conducted to compare the effectiveness of plasma care® versus placebo, both combined with best practice wound care.
Detailed description
Chronic wounds present a growing global health challenge, significantly affecting patients' quality of life and imposing high treatment costs. Despite advances in wound care, such as bioactive dressings and specialized medical personnel, effective treatment remains difficult due to the complexity of the wounds and underlying conditions.
Cold atmospheric plasma (CAP) has recently emerged as a promising treatment. CAP is created by ionizing gas with strong electric fields, producing reactive species that stimulate human cell regeneration while also exhibiting strong antibacterial and antifungal effects-even against antibiotic-resistant strains. This dual action makes CAP especially useful for chronic wounds, which are prone to infections.
CAP also benefits wound healing by lowering wound pH. Chronic wounds often have an alkaline environment conducive to bacterial growth, but CAP shifts the pH toward more acidic levels, supporting cell function and antibacterial activity.
Clinical studies have shown CAP significantly improves wound healing by promoting granulation tissue formation, reducing wound size and infection, and alleviating symptoms like redness and itching. CAP has also proven safe, with no mutagenic effects on healthy cells.
Different technologies exist to generate CAP, including Dielectric Barrier Discharge (DBD), Plasma Jet, and Surface Micro Discharge (SMD). The plasma care® device used in this study is based on SMD technology, allowing mobile, gas-free use to treat areas up to 13 cm², with treatment dose determined by application duration.
This study aims to evaluate whether plasma care® provides significantly better healing outcomes in chronic wounds of various types compared to placebo treatment. It also seeks to understand the impact of CAP on wound healing factors such as infection control, pH reduction, and exudate management, alongside patient experiences like pain and tolerability. If successful, this study could establish plasma care® as a valuable new option in chronic wound therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, multicenter, two-arm, randomized, single-blind, clinical study
| Arm | Type | Receives |
|---|---|---|
| Plasma arm | Active comparator | Device: Cold atmospheric plasmaTreatment of patients with cold atmospheric plasma |
| Placebo arm | Placebo comparator | Device: Placebo treatmentPlacebo control |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 95 years at the time of consent
- Presence of chronic wounds of any origin and wound phase (Includes locally infected wounds)
- Wound size up to 20 x 10 cm (If multiple wounds are present, one wound is designated as the study wound)
Key exclusion criteria (8 listed)
- Pregnant and breastfeeding women
- Patients on ongoing systemic antibiotic therapy or who received antibiotics within 1 week prior to study start
- Patients who participated in another study within one month prior to this study
- Patients with acute wounds
- Wounds with visible tendons and bones
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 plasmaTreatment of chronic wounds with cold plasma | Device | Plasma arm |
| Placebo treatmentTreatment of chronic wounds with the placebo device | Device | Placebo arm |
Primary outcome
Wound area at the end of the study
Time frame: 42 days
Size of the wound area (absolute) in cm2
Size and time course of the wound area at the end of the study
Time frame: 42 days
Average time course in size (absolute) of the wound area in cm2 per visit
Percentage change in wound area at the end of the study
Time frame: 42 days
Wound area as a percentage (from baseline)
Dynamics of the percentage change in wound area from baseline
Time frame: 42 days
Average time course of the percentage in wound area (compared to the initial value)
5 secondary outcomes
pH value
Time frame: 42 days
Pain Score
Time frame: 42 days
Infection Score
Time frame: 42 days
Tolerability of treatment
Time frame: 42 days
Subjective sensation
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No. Due to austrian legal privacy laws
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold atmospheric plasma in people with Hard to Heal Wounds and Infected Wound, run by Terraplasma Medical GmbH at 2 sites in Austria.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound area at the end of the study (time frame: 42 days). The study lists 4 primary outcomes in all. 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 3 Jul 2025.