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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cold Atmospheric Plasma treatment
DeviceParticipants in the intervention group will be treated with cold plasma therapy with Plasana One®, as an add-on to the standard of care.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Control ArmNo intervention 0 interventions
Group B: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The percentage of patients with Relative Wound Area Reduction (RWAR) ≥ 50% at week 6 from baseline, compared between intervention group and control group, for each indication, measured using digital planimetry software (Pixacare, CE Marked)
The percentage of patients with Relative Wound Area Reduction (RWAR) ≥ 50% at week 6 from baseline, compared between intervention group and control group, for each indication. With : RWAR; in % : \[(SD0 - SW6)/SD0\] x 100 SW6 : wound area at week 6 SD0 : wound area at D0 The wound area will be measured in a standardized way using digital planimetry with Pixacare software, guaranteeing a reproducible and objective measurement.
Time frame
From enrollment to week 6.Secondary outcomes
1
In each arm, the percentage of patients with Relative Wound Area Reduction (RWAR)≥ 50% at each week from baseline, measured using digital planimetry software (Pixacare, CE Marked)
With : RWAR; in % : \[(SD0 - SW6)/SD0\] x 100 SW6 : wound area at week 6 SD0 : wound area at D0 The wound area will be measured in a standardized way using digital planimetry with Pixacare software, guaranteeing a reproducible and objective measurement.
Time frame
Each week from baseline to week 20.2
Time to 100% re-epithelialization in the two patient groups
100% re-epithelialization will be assessed by the home healthcare provider or the investigational center of the patient, and confirmed by two other blinded investigators.
Time frame
From baseline to week 20.3
The percentage of wounds achieving complete closure defined by 100% re-epithelization, at W6, W12, W20, in both patient groups
100% re-epithelialization will be assessed by the home healthcare provider or the investigational center of the patient, and confirmed by two other blinded investigators.
Time frame
At week 6, at week 12 and week 20 post inclusion.4
In the two patient groups, the measurement of wound surface from baseline to W6, W12, W20, measured using digital planimetry software (Pixacare, CE Marked)
Time frame
At week 6, at week 12 and week 20 post inclusion.Other outcomes
1
The occurrence and seriousness of adverse events related to the use of Plasana One®
Time frame
From baseline to week 20.2
Score change from baseline based on the Wound-QOL-17 at week 6, at week 12 and week 20
Time frame
At week 6, at week 12 and week 20 post inclusion.3
Treatment pain evolution based on an Visual Analog Scale
Time frame
From baseline to week 20.4
Usability questionnaire completed at the end of the treatment period by the investigators and nurses, as final users of the device
Time frame
Week 20Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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