Plasma on Chronic Wounds for Epidermal Regeneration

NCT ID: NCT05855499

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-12-31

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.

Conditions

Chronic Ulcer of Lower Extremity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Plasma (CAPT)

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

Group Type: EXPERIMENTAL

CPtcube, CPTpatch

Intervention Type: DEVICE

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.

Standard wound treatment (SWT)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CPtcube, CPTpatch

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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:

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Coldplasmatech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Banaschik, Dr.

Role: STUDY_DIRECTOR

Coldplasmatech

Isabel Zänker, Dr.

Role: PRINCIPAL_INVESTIGATOR

Thüringen-Kliniken

Locations

Universitäts-Hautklinik Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status: NOT_YET_RECRUITING

Zentrum Rothenaicher

München, Bavaria, Germany

Site Status: RECRUITING

Zentrum Regensburg

Regensburg, Bavaria, Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Site Status: RECRUITING

Katholisches Klinikum Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Saxony, Germany

Site Status: RECRUITING

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Site Status: RECRUITING

Verbund Thüringen-Kliniken "Georgius Agricola"

Saalfeld, Thuringia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Robert Banaschik, Dr.

Role: CONTACT

banaschik@coldplasmatech.de

+49 3834 7714 700

Facility Contacts

Anke Strölin, Dr.

Role: primary

Gerhard Rothenaicher

Role: primary

Stefan Mann, Dr.

Role: primary

Matthias Augustin, Dr.

Role: primary

Markus Stücker, Dr.

Role: primary

Roland Aschoff, Dr.

Role: primary

Christian Hünefeld, Dr.

Role: primary

Isabel Zaenker, Dr.

Role: primary

Other Identifiers

CPT2019_01

Identifier Type: -

Identifier Source: org_study_id