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Plasma On Chronic Wounds for Epidermal Regeneration (POWER)

Primary Purpose

Chronic Ulcer of Lower Extremity

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CPtcube, CPTpatch
Sponsored by
Coldplasmatech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Ulcer of Lower Extremity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitäts-Hautklinik Tübingen
  • Zentrum RothenaicherRecruiting
  • Zentrum Regensburg
  • Katholisches Klinikum BochumRecruiting
  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität DresdenRecruiting
  • Verbund Thüringen-Kliniken "Georgius Agricola"Recruiting
  • Charité Universitätsmedizin BerlinRecruiting
  • Universitätsklinikum Hamburg-EppendorfRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Plasma (CAPT)

Standard wound treatment (SWT)

Arm Description

Conventional wound treatment according to S3 guideline, 3 visits weekly for 4 weeks, additive plasma treatment during each visit.

conventional wound treatment according to S3 guideline, 3 visits weekly for 4 weeks

Outcomes

Primary Outcome Measures

Reduction in area of chronic wounds
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

Secondary Outcome Measures

Wound closures
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).
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.
Change in quality of life
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.
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).

Full Information

First Posted
April 24, 2023
Last Updated
May 3, 2023
Sponsor
Coldplasmatech
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT05855499
Brief Title
Plasma On Chronic Wounds for Epidermal Regeneration
Acronym
POWER
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 -
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coldplasmatech
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ulcer of Lower Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plasma (CAPT)
Arm Type
Experimental
Arm Description
Conventional wound treatment according to S3 guideline, 3 visits weekly for 4 weeks, additive plasma treatment during each visit.
Arm Title
Standard wound treatment (SWT)
Arm Type
No Intervention
Arm Description
conventional wound treatment according to S3 guideline, 3 visits weekly for 4 weeks
Intervention Type
Device
Intervention Name(s)
CPtcube, CPTpatch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in area of chronic wounds
Description
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
Time Frame
3 visits weekly for 4 weeks, follow-up at at 12 and 20 weeks
Secondary Outcome Measure Information:
Title
Wound closures
Description
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).
Time Frame
during the 4-week active treatment phase, after 3 and after 6 months
Title
Change in wound pain
Description
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.
Time Frame
during the 6-month observation period
Title
Change in quality of life
Description
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.
Time Frame
during the 6-month observation period
Title
Amount of germs/bacteria in the wound bed
Description
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).
Time Frame
during the 4-week active treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Banaschik, Dr.
Phone
+49 3834 7714 700
Email
banaschik@coldplasmatech.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Banaschik, Dr.
Organizational Affiliation
Coldplasmatech
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isabel Zänker, Dr.
Organizational Affiliation
Thüringen-Kliniken
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäts-Hautklinik Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke Strölin, Dr.
Facility Name
Zentrum Rothenaicher
City
München
State/Province
Bayern
ZIP/Postal Code
81927
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Rothenaicher
Facility Name
Zentrum Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93047
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Mann, Dr.
Facility Name
Katholisches Klinikum Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44805
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Stücker, Dr.
Facility Name
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland Aschoff, Dr.
Facility Name
Verbund Thüringen-Kliniken "Georgius Agricola"
City
Saalfeld
State/Province
Thueringen
ZIP/Postal Code
07318
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Zaenker, Dr.
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Hünefeld, Dr.
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Augustin, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Plasma On Chronic Wounds for Epidermal Regeneration

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