Status:
NOT_YET_RECRUITING
Evaluation of Cold Plasma in Chronic Wound Healing
Lead Sponsor:
Plasana Medical
Conditions:
Chronic Wounds
Venous Leg Ulcer (VLU)
Eligibility:
All Genders
18+ years
Phase:
NA
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. Th...
Detailed Description
This is a multicenter, randomized, controlled clinical trial evaluating the efficacy and safety of cold atmospheric plasma (CAP) therapy using the Plasana One® device in the treatment of chronic wound...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06964048
Start Date
June 1 2025
End Date
May 1 2026
Last Update
May 9 2025
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