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

NCT07050667 | Completed

• 2 other identifiers: EK-2-3/2023PLASMACARE/70/Q1-23
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Hard to Heal Wounds; Infected Wound

Keywords

placebo controlled; plasma care; non thermal plasma; cold atmospheric plasma; wound healing; chronic wounds

Outcome Measures

Primary Outcomes (4)

• Wound area at the end of the study

  Size of the wound area (absolute) in cm2

  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

  42 days

• Percentage change in wound area at the end of the study

  Wound area as a percentage (from baseline)

  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)

  42 days

Secondary Outcomes (5)

• pH value

  42 days

• Pain Score

  42 days

• Infection Score

  42 days

• Tolerability of treatment

  42 days

• Subjective sensation

  42 days

Study Arms (2)

Plasma arm

ACTIVE COMPARATOR

Treatment of patients with cold atmospheric plasma

Device: Cold atmospheric plasma

Placebo arm

PLACEBO COMPARATOR

Placebo control

Device: Placebo treatment

Interventions

Cold atmospheric plasma DEVICE

Treatment of chronic wounds with cold plasma

Plasma arm

Placebo treatment DEVICE

Treatment of chronic wounds with the placebo device

Placebo arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Terraplasma Medical GmbH: lead

Study Sites (2)

LKH Bregenz

Bregenz, Austria

Location

LKH Feldkirch

Feldkirch, Austria

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, multicenter, two-arm, randomized, single-blind, clinical study

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 3, 2025
• Study Start: May 1, 2023
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)