Using cold plasma to heal chronic wounds

Plasma on Chronic Wounds for Epidermal Regeneration - Randomized, Controlled Clinical Trial to Investigate the Efficacy of Plasma Therapy for the Treatment of Chronic, Non-healing Wounds in Comparison to Standard Wound Therapy -

This study is testing a new cold plasma treatment to see if it can help heal stubborn wounds on the legs better than regular care alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 167 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Coldplasmatech (industry)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Tübingen, Baden-Württemberg and 7 other locations)
• Trial ID: NCT05855499 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a novel cold plasma therapy for treating chronic ulcers of the lower extremity. Participants will receive a 4-week initial plasma treatment in addition to standard wound care, with the primary goal of assessing wound area reduction as a measure of healing. Secondary outcomes will include various clinical parameters related to wound condition and patient-related outcomes such as pain perception and quality of life. The study aims to provide a reproducible method for applying cold plasma to larger wound areas, potentially improving healing times and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic, non-healing wounds on the lower leg that have persisted for at least 8 weeks.

Not a fit: Patients with wounds that do not meet the specified criteria or those with wounds that are undermined may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the healing process for patients with chronic wounds, leading to improved quality of life.

How similar studies have performed: Previous studies have shown promising results with cold plasma therapy for wound healing, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

Inclusion criteria are divided into patient-specific and wound-specific criteria.

Patient Criteria:

* Patient must be at least 18 years old (legal age) and legally competent
* The patient has at least one diagnosed chronic (existing for at least 8 weeks), non-healing wound due to a UCA or UCV on the lower leg, below the knee
* There is a signed consent form dated by the patient's own hand

Wound Criteria:

* In case of multiple wounds, the largest wound by area will be included in the study if it meets all inclusion criteria and no exclusion criteria and is suitable for use of the investigational product. The target wound is at least 2 cm away from the other wound(s)
* The wound was diagnosed - at the time of planned inclusion - more than 8 weeks ago and classified as a chronic wound
* The initial wound area is 5 cm²-100 cm2
* The wound can be enclosed completely by the plasma applicator (10 cm x 10 cm)
* The wound is not undermined
* The wound is located on the lower leg

Exclusion Criteria:

The exclusion criteria are divided into patient-specific and wound-specific criteria.

Patient Criteria:

* The patient is younger than 18 years and/or lacks legal capacity
* The patient has already participated in this study
* The patient is already participating in another interventional study
* Pregnant or breastfeeding patients
* The patient has an implanted pacemaker, defibrillator or other active implants
* The patient has a light/sun allergy
* The patient has a silicone allergy
* The patient has had a thrombosis within the last 3 months
* The patient has a systemic and/or chronic infectious disease (e.g., HIV, tuberculosis, hepatitis)
* The patient has a tumour disease
* An ongoing or recently completed chemotherapy or radiotherapy
* The patient is undergoing severe endogenous or drug immunosuppression
* The patient is receiving systemic antibiotic treatment or is receiving/needing antiseptic/antibiotic wound therapy in/near the wound
* The patient does not have the necessary revascularization (paVK)
* The patient requires vital instrumental monitoring in the sense of "basic monitoring": near-patient respiratory gas measurement (oxygen, carbon dioxide and inhalation anaesthetic), pulse oximeter, ECG monitoring, blood pressure measurement (non-invasive), an oscillometric blood pressure measurement with automatic mode
* Existing alcohol or drug abuse
* The patient requires dialysis

Wound Criteria:

* The wound is not a chronic wound as defined by study protocol
* The wound is difficult to access or close to exposed vessels
* The wound is critically colonized or infected
* Acute infections in the wound area (radius 5 cm)
* The wound is bleeding profusely. This does not include bleeding immediately after debridement
* The wound is undermined
* The wound is located at the knee or above

Where this trial is running

Tübingen, Baden-Württemberg and 7 other locations

• Universitäts-Hautklinik Tübingen — Tübingen, Baden-Württemberg, Germany (NOT_YET_RECRUITING)
• Zentrum Rothenaicher — München, Bayern, Germany (RECRUITING)
• Zentrum Regensburg — Regensburg, Bayern, Germany (NOT_YET_RECRUITING)
• Katholisches Klinikum Bochum — Bochum, Nordrhein-Westfalen, Germany (RECRUITING)
• Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden — Dresden, Sachsen, Germany (RECRUITING)
• Verbund Thüringen-Kliniken "Georgius Agricola" — Saalfeld, Thueringen, Germany (RECRUITING)
• Charité Universitätsmedizin Berlin — Berlin, Germany (RECRUITING)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (RECRUITING)

Study contacts

• Principal investigator: Isabel Zänker, Dr. — Thüringen-Kliniken
• Study coordinator: Robert Banaschik, Dr.

Conditions: Chronic Ulcer of Lower Extremity