An interventional study of Cold atmospheric plasma and Placebo treatment in Hard to Heal Wounds and Infected Wound, sponsored by Terraplasma Medical GmbH. Completed at 2 sites in Austria. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Terraplasma Medical GmbH · Not applicable, Interventional, and Treatment
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.
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.
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's enrollment of 70 is below the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →This is the only study on the registry with Terraplasma Medical GmbH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment of patients with cold atmospheric plasma
Device: Cold atmospheric plasma
Placebo control
Device: Placebo treatment
Treatment of chronic wounds with cold plasma
Treatment of chronic wounds with the placebo device
Wound area at the end of the study
Size of the wound area (absolute) in cm2
Time frame: 42 days
Size and time course of the wound area at the end of the study
Average time course in size (absolute) of the wound area in cm2 per visit
Time frame: 42 days
Percentage change in wound area at the end of the study
Wound area as a percentage (from baseline)
Time frame: 42 days
Dynamics of the percentage change in wound area from baseline
Average time course of the percentage in wound area (compared to the initial value)
Time frame: 42 days
pH value
pH measurement by pH meter
Time frame: 42 days
Pain Score
Pain as measured by the VAS Score (1 - 10)
Time frame: 42 days
Infection Score
Infection, measured by the PGA - Physician Global Assessment Score ranging from 0 (no signs of infection) to 4 (maximal signs of infection); 1-4 is considered infected
Time frame: 42 days
Tolerability of treatment
no problem (e.g. no maceration, deterioration of the wound, blisters) new development/intensification of erythema (maceration, blisters, exudate congestion)
Time frame: 42 days
Subjective sensation
Subjective sensation as given by the patient: 1 (pleasant feeling), 2 (no specific sensation), 3 (unpleasant), 4 (very unpleasant)
Time frame: 42 days
Plan to share: No — Due to austrian legal privacy laws
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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