Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT07050667
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2025-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo
Sponsor:
Terraplasma Medical GmbH
Organization:
Study Overview
Official Title:
Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo: a Multicenter, Two-arm, Randomized, Single-blind, Prospective, Clinical Study
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPCAP
Brief Summary:
Objective: The study aimed to evaluate the wound healing effects of plasma care®, a cold atmospheric plasma device, in patients with chronic wounds.
Method: A prospective, multicenter, two-arm, randomized, single-blind clinical trial was conducted to compare the effectiveness of plasma care® versus placebo, both combined with best practice wound care.
Method: A prospective, multicenter, two-arm, randomized, single-blind clinical trial was conducted to compare the effectiveness of plasma care® versus placebo, both combined with best practice wound care.
Detailed Description:
Chronic wounds present a growing global health challenge, significantly affecting patients' quality of life and imposing high treatment costs. Despite advances in wound care, such as bioactive dressings and specialized medical personnel, effective treatment remains difficult due to the complexity of the wounds and underlying conditions.
Cold atmospheric plasma (CAP) has recently emerged as a promising treatment. CAP is created by ionizing gas with strong electric fields, producing reactive species that stimulate human cell regeneration while also exhibiting strong antibacterial and antifungal effects-even against antibiotic-resistant strains. This dual action makes CAP especially useful for chronic wounds, which are prone to infections.
CAP also benefits wound healing by lowering wound pH. Chronic wounds often have an alkaline environment conducive to bacterial growth, but CAP shifts the pH toward more acidic levels, supporting cell function and antibacterial activity.
Clinical studies have shown CAP significantly improves wound healing by promoting granulation tissue formation, reducing wound size and infection, and alleviating symptoms like redness and itching. CAP has also proven safe, with no mutagenic effects on healthy cells.
Different technologies exist to generate CAP, including Dielectric Barrier Discharge (DBD), Plasma Jet, and Surface Micro Discharge (SMD). The plasma care® device used in this study is based on SMD technology, allowing mobile, gas-free use to treat areas up to 13 cm², with treatment dose determined by application duration.
This study aims to evaluate whether plasma care® provides significantly better healing outcomes in chronic wounds of various types compared to placebo treatment. It also seeks to understand the impact of CAP on wound healing factors such as infection control, pH reduction, and exudate management, alongside patient experiences like pain and tolerability. If successful, this study could establish plasma care® as a valuable new option in chronic wound therapy.
Cold atmospheric plasma (CAP) has recently emerged as a promising treatment. CAP is created by ionizing gas with strong electric fields, producing reactive species that stimulate human cell regeneration while also exhibiting strong antibacterial and antifungal effects-even against antibiotic-resistant strains. This dual action makes CAP especially useful for chronic wounds, which are prone to infections.
CAP also benefits wound healing by lowering wound pH. Chronic wounds often have an alkaline environment conducive to bacterial growth, but CAP shifts the pH toward more acidic levels, supporting cell function and antibacterial activity.
Clinical studies have shown CAP significantly improves wound healing by promoting granulation tissue formation, reducing wound size and infection, and alleviating symptoms like redness and itching. CAP has also proven safe, with no mutagenic effects on healthy cells.
Different technologies exist to generate CAP, including Dielectric Barrier Discharge (DBD), Plasma Jet, and Surface Micro Discharge (SMD). The plasma care® device used in this study is based on SMD technology, allowing mobile, gas-free use to treat areas up to 13 cm², with treatment dose determined by application duration.
This study aims to evaluate whether plasma care® provides significantly better healing outcomes in chronic wounds of various types compared to placebo treatment. It also seeks to understand the impact of CAP on wound healing factors such as infection control, pH reduction, and exudate management, alongside patient experiences like pain and tolerability. If successful, this study could establish plasma care® as a valuable new option in chronic wound therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PLASMACARE/70/Q1-23 | OTHER | LKH Feldkirch | View |