Evaluation of Cold Plasma in Chronic Wound Healing

NCT06964048 | Not Yet Recruiting

• 1 other identifier: IC202401
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds. The main questions is the following: Does the application of cold atmospheric plasma accelerate wound healing compared to standard wound care alone? Researchers will compare standard of care plus plasma treatment with standard of care alone to see if the plasma-treated group shows faster wound healing. Participants will:

• Receive either standard wound care alone or standard wound care combined with cold atmospheric plasma treatment, depending on randomization.
• Attend scheduled hospital visits for wound care, treatment administration, and clinical assessments, including wound photography and quality of life questionnaires.
• Be followed up at home by nurses for wound care, treatment administration and clinical assessment too.
• Complete a wound-related quality of life questionnaire at baseline, at week 6, and at the end of the study.

Conditions

Chronic Wounds; Venous Leg Ulcer (VLU); Diabetic Foot Ulcer (DFU); Pressure Ulcer (PU)

Keywords

Chronic wounds; Venous Leg Ulcer; VLU; Diabetic Foot Ulcer; DFU; Pressure Ulcer; PU; Cold Atmospheric Plasma; CAP; Plasma; Cold Plasma; Healing; Wound Closure

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with Relative Wound Area Reduction (RWAR) ≥ 50% at week 6 from baseline, compared between intervention group and control group, for each indication, measured using digital planimetry software (Pixacare, CE Marked)

  The percentage of patients with Relative Wound Area Reduction (RWAR) ≥ 50% at week 6 from baseline, compared between intervention group and control group, for each indication. With : RWAR; in % : \[(SD0 - SW6)/SD0\] x 100 SW6 : wound area at week 6 SD0 : wound area at D0 The wound area will be measured in a standardized way using digital planimetry with Pixacare software, guaranteeing a reproducible and objective measurement.

  From enrollment to week 6.

Secondary Outcomes (5)

• In each arm, the percentage of patients with Relative Wound Area Reduction (RWAR)≥ 50% at each week from baseline, measured using digital planimetry software (Pixacare, CE Marked)

  Each week from baseline to week 20.

• Time to 100% re-epithelialization in the two patient groups

  From baseline to week 20.

• The percentage of wounds achieving complete closure defined by 100% re-epithelization, at W6, W12, W20, in both patient groups

  At week 6, at week 12 and week 20 post inclusion.

• In the two patient groups, the measurement of wound surface from baseline to W6, W12, W20, measured using digital planimetry software (Pixacare, CE Marked)

  At week 6, at week 12 and week 20 post inclusion.

• In each arm, the number of care procedures (SOC only or SOC + CAP) will be compared between the distinct time points

  From baseline to week 20.

Other Outcomes (5)

• The occurrence and seriousness of adverse events related to the use of Plasana One®

  From baseline to week 20.

• Score change from baseline based on the Wound-QOL-17 at week 6, at week 12 and week 20

  At week 6, at week 12 and week 20 post inclusion.

• Treatment pain evolution based on an Visual Analog Scale

  From baseline to week 20.

Study Arms (2)

Control Arm

NO INTERVENTION

Participants in the control group will receive the standard of care alone.

Intervention Arm

EXPERIMENTAL

Participants in the intervention group will be treated according to the same protocol as the control group, with the addition of cold plasma therapy with Plasana One®, as an add-on to the standard of care.

Device: Cold Atmospheric Plasma treatment

Interventions

Cold Atmospheric Plasma treatment DEVICE

Participants in the intervention group will be treated with cold plasma therapy with Plasana One®, as an add-on to the standard of care.

Also known as: CAP treatment, Plasma treatment, Plasma application, CAP application, Cold plasma therapy

Intervention Arm

Eligibility Criteria

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

You may qualify if:

• Adult patient, age ≥ 18 years,
• Patients affiliated with a social security system or benefiting from such a system,
• Patients able and willing to provide written informed consent,
• Patients able and willing to attend regular follow-up visits during up to 20 weeks, and comply with study procedures,
• Patients whose home healthcare professional is willing to follow the clinical investigation protocol,
• Patient with gas conformed stockage area (ventilated or at least 7m²)
• Patients without infection, or with a local controlled infection,
• Patients with VLU:
• Patients with wound anteriority between 1 to 12 months
• Patients with VLU or mixed ulcer of predominantly venous origin (measured ankle brachial index (ABI) such as 1.3 ≥ ABI ≥ 0.8)
• Patients with VLU between 4 to 30 cm² in surface area,
• Patients with only one VLU,
• Patients who have not shown wound healing improvement after wearing compression system for at least two weeks
• Patients with DFU:
• Patients with wound duration between 1 to 12 months

You may not qualify if:

• Patients with any other wound treatments other than SOC, Patients who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) since less than three months, except for VLU patients who have undergone local graft surgery included in VLU SOC.
• Patients with an active Charcot's neuro-arthropathy as determined by clinical and/or radiographic examination,
• Patients with critical limb ischemia or severe PAD (ankle pressure \< 50 mmHg or Toe pressure \< 30 mmHg).
• Patients with conditions that may affect wound healing, such as rheumatoid arthritis, scleroderma, or tumor wounds.
• Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant,
• Patients with non-controlled systemic infection by a suitable antibiotic,
• Patients with suspicion of severe malnutrition,
• Pregnancy or breastfeeding woman, or susceptible to be pregnant,
• Patients with known allergy or hypersensitivity to components of the cold plasma device or standard wound care products,
• Patients included in another study,
• Patients under guardianship or protection of vulnerable adult.
• Patients with implantable electro-medical devices.
• Patients with a history of hypersensitivity or known allergy to medical argon or any component of the device.
• Infected wounds requiring urgent medical or surgical treatment before the application of any device.

Sponsors & Collaborators

• Plasana Medical: lead

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot; Pressure Ulcer

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Dured Dardari, MD, PhD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwénaëlle Droguet

CONTACT

+336 61 64 12 48; gwenaelle.droguet@plasana-medical.com

Yves Matton

CONTACT

+33 6 63 28 03 61; yves.matton@plasana-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 9, 2025
• Study Start: June 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-04