NCT05855499

Plasma On Chronic Wounds for Epidermal Regeneration

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 -

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Coldplasmatech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-05-11
• Last updated: 2026-03-18

Locations

8 sites across 1 country: Germany