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NCT06964048

Evaluation of Cold Plasma in Chronic Wound Healing

Sponsor: Plasana Medical

View on ClinicalTrials.gov

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.

Official title: Evaluation of Cold Plasma in Wound Healing: A Randomized Controlled Pilot Study on Chronic Venous Leg Ulcers and Diabetic Foot Ulcers.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06

Completion Date

2026-05

Last Updated

2025-05-09

Healthy Volunteers

Conditions

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

Interventions

DEVICE

Cold Atmospheric Plasma treatment

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

Inclusion Criteria: * 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 * Patients with DFU and with measured ABI ≥ 0.8 or Toe Brachial Index (TBI) ≥ 0.7 * Patients with DFU between 1 to 30 cm² in surface area, * Patients with only one DFU, not between toes, * Patients who have not shown wound healing improvement after wearing an offloading system for at least two weeks, * Patient with PU: * Patient with wound duration between 1 to 12 months * Patient with PU stage 2 or 3 NPUAP grade, * Patient with PU and with ABPI ≥ 0.8 and ≤ 1.3 and/or Toe Brachial Index (TBI) ≥ 0.7 if PU on the foot * Patient with PU between 4 to 30 cm² in surface area, * Patient with only one PU * Patient able and willing to wear off loading system or to be install on pressure relieving system et changing position regularly, Exclusion Criteria: * 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.