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Chronic Ulcer of Lower ExtremityPOWERNCT05855499

Plasma On Chronic Wounds for Epidermal Regeneration

A study testing CPtcube, CPTpatch in people with Chronic Ulcer of Lower Extremity, run by Coldplasmatech at 8 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Every year, 5 million people throughout Germany suffer from extensive, often chronic wounds. Cold plasma is an innovative therapeutic approach in the treatment of these persistent tissue defects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Ulcer of Lower Extremity
What is being tested?
CPtcube, CPTpatch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
8 sitesGermany
Study dates
1 Oct 2021to 31 Dec 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

  • Inclusion criteria are divided into patient-specific and wound-specific criteria.
  • Patient Criteria:
  • Patient must be at least 18 years old (legal age) and legally competent
  • The patient has at least one diagnosed chronic (existing for at least 8 weeks), non-healing wound due to a UCA or UCV on the lower leg, below the knee
  • There is a signed consent form dated by the patient's own hand
  • Wound Criteria:
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  • In case of multiple wounds, the largest wound by area will be included in the study if it meets all inclusion criteria and no exclusion criteria and is suitable for use of the investigational product. The target wound is at least 2 cm away from the other wound(s)
  • The wound was diagnosed - at the time of planned inclusion - more than 8 weeks ago and classified as a chronic wound
  • The initial wound area is 5 cm²-100 cm2
  • The wound can be enclosed completely by the plasma applicator (10 cm x 10 cm)
  • The wound is not undermined
  • The wound is located on the lower leg

Who cannot join

  • The exclusion criteria are divided into patient-specific and wound-specific criteria.
  • Patient Criteria:
  • The patient is younger than 18 years and/or lacks legal capacity
  • The patient has already participated in this study
  • The patient is already participating in another interventional study
  • Pregnant or breastfeeding patients
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  • The patient has an implanted pacemaker, defibrillator or other active implants
  • The patient has a light/sun allergy
  • The patient has a silicone allergy
  • The patient has had a thrombosis within the last 3 months
  • The patient has a systemic and/or chronic infectious disease (e.g., HIV, tuberculosis, hepatitis)
  • The patient has a tumour disease
  • An ongoing or recently completed chemotherapy or radiotherapy
  • The patient is undergoing severe endogenous or drug immunosuppression
  • The patient is receiving systemic antibiotic treatment or is receiving/needing antiseptic/antibiotic wound therapy in/near the wound
  • The patient does not have the necessary revascularization (paVK)
  • The patient requires vital instrumental monitoring in the sense of "basic monitoring": near-patient respiratory gas measurement (oxygen, carbon dioxide and inhalation anaesthetic), pulse oximeter, ECG monitoring, blood pressure measurement (non-invasive), an oscillometric blood pressure measurement with automatic mode
  • Existing alcohol or drug abuse
  • The patient requires dialysis
  • Wound Criteria:
  • The wound is not a chronic wound as defined by study protocol
  • The wound is difficult to access or close to exposed vessels
  • The wound is critically colonized or infected
  • Acute infections in the wound area (radius 5 cm)
  • The wound is bleeding profusely. This does not include bleeding immediately after debridement
  • The wound is undermined
  • The wound is located at the knee or above

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites

  • Charité Universitätsmedizin Berlin

    Berlin, State of Berlin, 10117

  • Katholisches Klinikum Bochum

    Bochum, North Rhine-Westphalia, 44805

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, Saxony, 01307

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Zentrum Rothenaicher

    München, Bavaria, 81927

  • Zentrum Regensburg

    Regensburg, Bavaria, 93047

  • Verbund Thüringen-Kliniken "Georgius Agricola"

    Saalfeld, Thuringia, 07318

  • Universitäts-Hautklinik Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

Official title: Plasma On Chronic Wounds for Epidermal Regeneration - Randomized, Controlled Clinical Trial to Investigate the Efficacy of Plasma Therapy for the Treatment of Chronic, Non-healing Wounds in Comparison to Standard Wound Therapy -

Every year, 5 million people throughout Germany suffer from extensive, often chronic wounds. Cold plasma is an innovative therapeutic approach in the treatment of these persistent tissue defects. However, previous therapy options with cold plasma are very time-consuming, especially with increasing wound area, and are also strongly dependent on the skill of the practitioner.

This study investigates the effectiveness of a system for reproducible application of cold plasma on larger areas and observes the effect of a 4-week additional plasma treatment on wound healing of large chronic wounds. The patient-related benefit of such an additional treatment will also be evaluated. Both study arms will receive guideline-based wound therapy, which is the current gold standard.

Read the detailed description

The clinical trial investigates the efficacy of an additional 4-week initial plasma therapy (CAPT) in direct comparison to standard guideline-based wound therapy (SWT) alone. The reactivation of healing of chronic, non-healing wounds will be assessed. This reactivation is primarily measured by the reduction of wound area, a valid and clinically accepted parameter for wound healing. A large number of RCTs and cohort studies demonstrate a strong correlation between the reduction in wound area at 4 weeks and the therapy outcome at 12 and 20 weeks.

In addition to wound area reduction, other clinical parameters such as wound volume, wound closure, percentage of necrotic and fibrotic tissue, percentage of granulation tissue, wound exudate, and microflora are recorded. By recording these secondary endpoints, it is possible to closely track and analyse changes in wound condition induced by cold plasma.

Another focus of the clinical trial is the evaluation of patient-related outcomes such as frequency of occurrence of infections, perception of pain, occurrence of adverse events, frequency of hospitalization, and change in quality of life. These events are fully documented to evaluate the safety of the treatment and to rule out potential risks.

Being tested
CPtcube, CPTpatch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPtcube, CPTpatchDevice

    This study investigates the effectiveness of a system for reproducible application of cold plasma on larger areas and observes the effect of a 4-week additional plasma treatment on wound healing of large chronic wounds.

Study groups in NCT05855499
Study groupRoleWhat they receive
Plasma (CAPT)ExperimentalConventional wound treatment according to S3 guideline, 3 visits weekly for 4 weeks, additive plasma treatment during each visit.
Receives: Device: CPtcube, CPTpatch
Standard wound treatment (SWT)No interventionconventional wound treatment according to S3 guideline, 3 visits weekly for 4 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in area of chronic wounds

    Chronic wound area is measured in square centimeters (cm²) using the SilhouetteStar® computer-assisted image-based wound measurement system. The outcome is the absolute change in wound area from baseline to Day 25, calculated as wound area at Day 25 minus wound area at baseline.

    Measured: 3 visits weekly for 4 weeks

  2. Change from baseline in SF-12 Mental Component Summary score at Day 25

    Mental health-related quality of life is measured using the Mental Component Summary score of the 12-Item Short Form Health Survey (SF-12). The outcome is the change in the SF-12 Mental Component Summary score from baseline to Day 25, expressed in points. The SF-12 scale ranges from 0 to 100, where 50 represents the population average and higher scores indicate a better health status.

    Measured: 3 visits weekly for 4 weeks

Secondary outcomes (3)

  1. Wound closures

    Number of participants with wound closure during the 4-week active treatment phase and at the 3-month and 6-month follow-up assessments.

    Measured: during the 4-week active treatment phase, after 3 and after 6 months

  2. Change in wound pain

    Change in wound pain during activity or at rest during the 6-month observation period. Pain was assessed using an NRS with values ranging from 0 to 10. Higher scores indicate worse pain.

    Measured: during the 6-month observation period

  3. Change in the amount of germs/bacteria in the wound bed

    For this purpose, swabs are taken before and after treatment. The swabs are then examined in the laboratory with regard to the microflora (germ type and resistance). The bacterial load is measured on a logarithmic scale. Lower values indicate a lower bacterial load and therefore a better outcome.

    Measured: during the 4-week active treatment phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start1 Oct 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05855499
Sponsor's protocol ID
CPT2019_01
Acronym
POWER
Status last verified
Sep 2026
First submitted
24 Apr 2023
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing CPtcube, CPTpatch in people with Chronic Ulcer of Lower Extremity, run by Coldplasmatech at 8 sites in Germany.

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 12 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. 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?

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?

Change in area of chronic wounds (time frame: 3 visits weekly for 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05855499.

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 14 Sep 2026.

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