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Evaluation of Cold Plasma in Chronic Wound Healing

NCT06964048 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-05-09

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Plasana Medical

    lead INDUSTRY

Principal Investigators

  • Dured Dardari, MD, PhD · Centre Hospitalier Sud Francilien

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-01-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06964048 on ClinicalTrials.gov