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Plasma On Chronic Wounds for Epidermal Regeneration

NCT05855499 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-18

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Coldplasmatech

    lead INDUSTRY

Principal Investigators

  • Robert Banaschik, Dr. · Coldplasmatech

  • Isabel Zänker, Dr. · Thüringen-Kliniken

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05855499 on ClinicalTrials.gov