Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo (SUPCAP)

Terraplasma Medical GmbH

Status

Completed

Conditions

Infected Wound

Hard to Heal Wounds

Treatments

Device: Cold atmospheric plasma

Device: Placebo treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT07050667

PLASMACARE/70/Q1-23 (Other Identifier)

EK-2-3/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 95 years at the time of consent
Presence of chronic wounds of any origin and wound phase (Includes locally infected wounds)
Wound size up to 20 x 10 cm (If multiple wounds are present, one wound is designated as the study wound)

Exclusion criteria

Pregnant and breastfeeding women
Patients on ongoing systemic antibiotic therapy or who received antibiotics within 1 week prior to study start
Patients who participated in another study within one month prior to this study
Patients with acute wounds
Wounds with visible tendons and bones
Wounds with more than 30% dry necrosis
Allergy or intolerance to cold plasma
Patients with wounds covered by primary or secondary dressings