Evaluation of Cold Plasma in Chronic Wound Healing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPlasana Medical
About this trial
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.
Eligibility criteria
Qualifiers
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,
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cold Atmospheric Plasma treatment
Treatment groups
66 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov