Evaluation of Cold Plasma in Chronic Wound Healing

Launched by PLASANA MEDICAL · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called cold atmospheric plasma can help heal chronic wounds more effectively than standard wound care alone. Chronic wounds include conditions like venous leg ulcers, diabetic foot ulcers, and pressure ulcers. The researchers want to find out if applying this cold plasma treatment can speed up the healing process for adult patients suffering from these types of wounds.

To participate, you must be at least 18 years old and able to attend regular follow-up visits for up to 20 weeks. You should have a chronic wound that has not improved with regular treatments. During the trial, you will either receive standard wound care alone or standard care combined with cold plasma treatment. You'll have scheduled visits at the hospital for care and assessments, and nurses will follow up with you at home. Throughout the study, you'll also complete questionnaires about your quality of life related to your wound. This trial is not yet recruiting participants, but it aims to provide valuable insights into new treatments for chronic wounds.

Gender

ALL

Eligibility criteria

• 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.