PLASOMA Efficacy & Technology Health (PETH) Study

Study Overview
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Brief Summary
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This study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad. The intention is that the data obtained with this study will be used to: Demonstrate comparative performance of PLASOMA (for two treatment frequencies) Provide evidence for health technology assessments (HTA) of PLASOMA

Detailed Description
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The PETH study will be an open label three-armed randomized controlled trial (RCT) on chronic VLU. The study will be performed at one study site in the Netherlands. The three arms are: Control group: standard care for 12 weeks or until healing, whichever occurs first; Treatment group-1: standard care + PLASOMA treatment once per week for 12 weeks or until healing, whichever occurs first; Treatment group-2: standard care + PLASOMA treatment twice per week for 12 weeks or until healing, whichever occurs first. After the treatment period there will be two follow up timepoints: 2 weeks after the end of the treatment period (FU1) and 12 weeks after the end of the treatment period (FU2). Subjects will be allocated to one of the three arms according to a pre-defined randomization schedule. Primary study parameters/outcome of the study: Evaluate the percentage of wounds healed after 12 weeks of treatment with PLASOMA for two treatment frequencies: once per week and twice per week. This will be done by comparing the treatment groups with the control group

Official Title
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PLASOMA Efficacy & Technology Health (PETH) Study: A Post-market Randomised Controlled Efficacy Study of PLASOMA on Wound Healing in Chronic Venous Leg Ulcers

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: PLASOMA


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: INCL1: have a slow-healing or non-healing lower leg ulcer presumed to be caused by venous insufficiency (VLU). The wound should have insufficient healing (<30% surface area reduction) during the last 2 weeks of standard wound care. INCL2: have a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 6 cm ( 28 cm2 wound surface area for circular wounds). INCL3: have an Ankle Brachial Pressure Index (ABPI) between 0.8 and 1.3. Note 1: subject can be included based on a VLU diagnosis from anamnesis. Make sure an ABPI measurement is performed as soon as possible to verify the diagnosis. The subject has to be excluded if the ABPI is not between 0.8 and 1.3. Note 2: For diabetic patients an ABPI measurement is not always reliable. Therefore, diabetic patients can be included based on a VLU diagnosis from anamnesis, but no ABPI measurement needs to be performed. INCL4: have a minimum age of 18 years old. INCL5: For home care treatments only: there is a grounded wall socket available for connection of PLASOMA. Exclusion Criteria: EXCL1: the subject has one or more of the following contraindications for PLASOMA: the wound is very exudative, i.e. wounds in which moisture is visible again within a few minutes after patting dry. any implanted active electronic device, such as a pacemaker, is present. an electronic medical device is attached to the body, including electronic life support equipment, hearing aids, glucose sensors and insulin pumps. If the sole purpose of the medical device is monitoring, the subject is not excluded, but it should be noted that use of PLASOMA together with such devices has not been tested and may lead to erroneous operation of the attached device during PLASOMA treatment. Note: no exclusion if electronic medical device will be detached during PLASOMA treatment. a metal implant (including a stent) is present in the treatment area, i.e. the area between pad and electrode. a conductive connection from outside to inside the body at or near the heart is present, e.g. a catheter with electrolyte fluid. the subject has epilepsy the subject is pregnant EXCL2: the subject uses systemic antibiotics. EXCL3: the subject has any known malignant wound degeneration. EXCL4: the subject receives treatment with immunosuppressive agents or oral corticosteroids; no exclusion if subject has received a stable dose for at least 2 months and the oral corticosteroid dose does not exceed 7.5 mg/day prednisone or equivalent. EXCL5: the subject is receiving or likely to receive advanced wound dressings or advanced therapies- such as negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth factors), electrophysical therapy - for the to-be-treated wound. EXCL6: the subject cannot (agree to) comply with the SOC. EXCL7: the subject participates in another study which is likely to compromise the outcome of the PETH study or the feasibility of thesubject fulfilling the PETH study. EXCL8: the subject is unable to provide consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: 1x PLASOMA<br> | Device: PLASOMA<br>* Treatment with cold plasma device<br>|
| Experimental: 2x PLASOMA<br> | Device: PLASOMA<br>* Treatment with cold plasma device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the percentage of wounds healed after 12 weeks of treatment with PLASOMA for two treatment frequencies: once per week and twice per week |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing |  | 4 weeks | 
| Time to healing |  | until 12 weeks | 
| % Wounds with wound surface area reduction ≥50% |  | 4 weeks | 
| Wound surface area reduction |  | 4 weeks | 
| Wound surface area reduction |  | 12 weeks | 
| Wound volume reduction |  | 4 weeks | 
| Wound volume reduction |  | 12 weeks | 
| Number of recurrences |  | 5 weeks | 
| Number of recurrences |  | 9 weeks | 
| Number of recurrences |  | 12 weeks | 
| Scarring |  | FU1 (2 weeks after end of treatment) | 
| Scarring |  | FU2 (12 weeks after end of treatment) | 
| Quality of life - general | RAND-36 questionnaire | FU1 (2 weeks after end of treatment) | 
| Quality of life - wound specific | Wound-QOL questionnaire | FU1 (2 weeks after end of treatment) | 
| Wound pain | wound pain, using 0-10 numerical rating scale | 20 weeks | 
| Wound infection | wound infection (clinical classification) | until FU2 (12 weeks after end of treatment) | 
| Health Technology Assessment | resources used | 20 weeks | 
| Patient acceptability | subjects will be asked if they are happy with the PLASOMA treatment | 20 weeks | 
| Adverse Events with a potential relation to PLASOMA |  | 20 weeks |