Plasma On Chronic Wounds for Epidermal Regeneration

NCT05855499 | Active Not Recruiting DMC

• 1 other identifier: CPT2019_01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Ulcer of Lower Extremity

Outcome Measures

Primary Outcomes (1)

• 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

  3 visits weekly for 4 weeks, follow-up at at 12 and 20 weeks

Secondary Outcomes (4)

• Wound closures

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

• Change in wound pain

  during the 6-month observation period

• Change in quality of life

  during the 6-month observation period

• Amount of germs/bacteria in the wound bed

  during the 4-week active treatment phase

Study Arms (2)

Plasma (CAPT)

EXPERIMENTAL

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

Device: CPtcube, CPTpatch

Standard wound treatment (SWT)

NO INTERVENTION

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

Interventions

CPtcube, CPTpatch 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.

Plasma (CAPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Coldplasmatech: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (8)

Universitäts-Hautklinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Zentrum Rothenaicher

München, Bavaria, 81927, Germany

Location

Zentrum Regensburg

Regensburg, Bavaria, 93047, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Katholisches Klinikum Bochum

Bochum, North Rhine-Westphalia, 44805, Germany

Location

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Saxony, 01307, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Verbund Thüringen-Kliniken "Georgius Agricola"

Saalfeld, Thuringia, 07318, Germany

Location

Study Officials

• Robert Banaschik, Dr.

  Coldplasmatech

  STUDY DIRECTOR

• Isabel Zänker, Dr.

  Thüringen-Kliniken

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 11, 2023
• Study Start: October 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

DE (8)