- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855499
Plasma On Chronic Wounds for Epidermal Regeneration (POWER)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert Banaschik, Dr.
- Phone Number: +49 3834 7714 700
- Email: banaschik@coldplasmatech.de
Study Locations
-
-
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Berlin, Germany, 10117
- Recruiting
- Charité Universitätsmedizin Berlin
-
Contact:
- Christian Hünefeld, Dr.
-
Hamburg, Germany, 20246
- Recruiting
- Universitätsklinikum Hamburg-Eppendorf
-
Contact:
- Matthias Augustin, Dr.
-
-
Baden-Württemberg
-
Tübingen, Baden-Württemberg, Germany, 72076
- Not yet recruiting
- Universitäts-Hautklinik Tübingen
-
Contact:
- Anke Strölin, Dr.
-
-
Bayern
-
München, Bayern, Germany, 81927
- Recruiting
- Zentrum Rothenaicher
-
Contact:
- Gerhard Rothenaicher
-
Regensburg, Bayern, Germany, 93047
- Not yet recruiting
- Zentrum Regensburg
-
Contact:
- Stefan Mann, Dr.
-
-
Nordrhein-Westfalen
-
Bochum, Nordrhein-Westfalen, Germany, 44805
- Recruiting
- Katholisches Klinikum Bochum
-
Contact:
- Markus Stücker, Dr.
-
-
Sachsen
-
Dresden, Sachsen, Germany, 01307
- Recruiting
- Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
-
Contact:
- Roland Aschoff, Dr.
-
-
Thueringen
-
Saalfeld, Thueringen, Germany, 07318
- Recruiting
- Verbund Thüringen-Kliniken "Georgius Agricola"
-
Contact:
- Isabel Zaenker, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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:
- 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
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plasma (CAPT)
Conventional wound treatment according to S3 guideline, 3 visits weekly for 4 weeks, additive plasma treatment during each visit.
|
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.
|
No Intervention: Standard wound treatment (SWT)
conventional wound treatment according to S3 guideline, 3 visits weekly for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in area of chronic wounds
Time Frame: 3 visits weekly for 4 weeks, follow-up at at 12 and 20 weeks
|
The clinical trial is based on the following primary null hypothesis (H0): There is no significant difference in terms of reduction in area of chronic wounds between standard guideline-based wound therapy with and without initial 4-week plasma treatment. The associated alternative hypothesis (HA) is: There is a significant difference in terms of reduction in area of chronic wounds between standard guideline-based wound therapy with and without initial 4 weeks of plasma treatment |
3 visits weekly for 4 weeks, follow-up at at 12 and 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound closures
Time Frame: during the 4-week active treatment phase, after 3 and after 6 months
|
Number of patients with wound closures achieved during the 4-week active treatment phase or in the period after the active treatment phase (3 or 6 months after last visit).
|
during the 4-week active treatment phase, after 3 and after 6 months
|
Change in wound pain
Time Frame: during the 6-month observation period
|
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.
|
during the 6-month observation period
|
Change in quality of life
Time Frame: during the 6-month observation period
|
Change in quality of life, assessed using a wound-specific questionnaire (Wound-QoL) and a generic quality-of-life questionnaire (SF-12), at the end of the treatment phase, at wound closure, at early treatment discontinuation, and during the two FU time points, each compared with the start of treatment.
|
during the 6-month observation period
|
Amount of germs/bacteria in the wound bed
Time Frame: during the 4-week active treatment phase
|
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).
|
during the 4-week active treatment phase
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Robert Banaschik, Dr., Coldplasmatech
- Principal Investigator: Isabel Zänker, Dr., Thüringen-Kliniken
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPT2019_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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