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

NCT ID: NCT07050667

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-12-13

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.

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.

Conditions

Hard to Heal Wounds; Infected Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Plasma arm

Treatment of patients with cold atmospheric plasma

Group Type: ACTIVE_COMPARATOR

Cold atmospheric plasma

Intervention Type: DEVICE

Treatment of chronic wounds with cold plasma

Placebo arm

Placebo control

Group Type: PLACEBO_COMPARATOR

Placebo treatment

Intervention Type: DEVICE

Treatment of chronic wounds with the placebo device

Interventions

Cold atmospheric plasma

Treatment of chronic wounds with cold plasma

Intervention Type: DEVICE

Placebo treatment

Treatment of chronic wounds with the placebo device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terraplasma Medical GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LKH Bregenz

Bregenz, , Austria

LKH Feldkirch

Feldkirch, , Austria

Countries

Austria

Other Identifiers

PLASMACARE/70/Q1-23

Identifier Type: OTHER

Identifier Source: secondary_id

EK-2-3/2023

Identifier Type: -

Identifier Source: org_study_id