NCT06964048

Evaluation of Cold Plasma in Chronic Wound Healing

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Plasana Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 wounds. The study aims to compare the outcomes of standard of care alone versus standard of care combined with plasma treatment. 60 eligible participants presenting with chronic wounds (such as venous leg ulcers or diabetic foot ulcers) will be randomized into two groups: * One group will receive standard wound care as per clinical practice. * The other group will receive standard wound care along with cold plasma therapy administered using the Plasana One® device. 6 participants suffering from pressure ulcers will also be included for an ancillary study. The study includes both hospital-based and home-based components. Key study procedures include wound assessment through photography, clinical data collection using an electronic case report form (eCRF), and evaluation of patient-reported outcomes such as quality of life (Wound-QoL questionnaire). Treatments and follow-up visits will be conducted by hospital investigators and home healthcare professionals, depending on the participant's care pathway. Plasma treatment will be delivered by trained nurses during home visits, with gas supplies and device management coordinated by a home care service provider (PSAD). The primary objective is to evaluate the efficacy of the cold plasma device Plasana One® in the local management of chronic wounds in participants suffering from diabetic foot ulcers and venous leg ulcers, at Week 6. Secondary objectives include wound healing progression, quality of life, safety of plasma application, and user satisfaction over a 20-week period. The objective of the ancillary study will be to describe the healing process in pressure ulcers.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-01-01
• Completion: 2026-05-01
• First posted: 2025-05-09
• Last updated: 2025-05-09