PLASOMA Efficacy & Technology Health (PETH) Study

Overview

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: 1. Demonstrate comparative performance of PLASOMA (for two treatment frequencies) 2. Provide evidence for health technology assessments (HTA) of PLASOMA

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2022

Detailed Description

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 20 weeks or until healing, whichever occurs first; – Treatment group-1: standard care + PLASOMA treatment once per week for 20 weeks or until healing, whichever occurs first; – Treatment group-2: standard care + PLASOMA treatment twice per week for 20 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

Interventions

  • Device: PLASOMA
    • Treatment with cold plasma device

Arms, Groups and Cohorts

  • No Intervention: Control group
  • Experimental: 1x PLASOMA
  • Experimental: 2x PLASOMA

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the percentage of wounds healed after 12 weeks of treatment with PLASOMA for two treatment frequencies: once per week and twice per week
    • Time Frame: 12 weeks

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • INCL1: have a slow-healing or non-healing lower leg ulcer presumed to be caused by venous insufficiency. The wound should exist for at least 3 weeks. – Note: There is no upper limit for the duration that the wound exists. In case a subject has multiple wounds that meet the in- and exclusion criteria, the wound with the longest duration will be chosen for the study. – INCL2: have insufficient healing (<30% surface area reduction during the last two weeks of standard wound care). – INCL3: have a wound with a wound surface area that matches the size of the plasma area of the pad (for the currently CE approved pad C0801 that is a maximum diameter of 3 cm). – INCL4: have a wound with a minimum wound size of 1 cm2. – INCL5: have an Ankle Brachial Pressure Index (ABPI) between 0.8 and 1.3. – Note: 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 do not haveto meet INCL5. – INCL6: are willing to perform a study visit (at home or at the study site) twice a week. – INCL7: are willing and physically able to carry out all study procedures. – INCL8: have a minimum age of 18 years old. – INCL9: For home care treatments only: there is a grounded wall socket available for connection of PLASOMA. Exclusion Criteria:

  • EXCL1: the subject has a mixed aetiology (venous and arterial) leg ulcer. – EXCL2: the subject has an ulcer on the foot or the knee. – EXCL3: the wound is very exudative, i.e. wounds in which moisture is visible again within a few minutes after patting dry. – EXCL4: any implanted active electronic device, such as a pacemaker, is present. – EXCL5: an electronic medical device is attached to the body, including electronic life support equipment 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. – EXCL6: a metal implant (including a stent) is present in the treatment area, i.e. the area between pad and electrode. – EXCL7: a conductive connection from outside to inside the body at or near the heart is present, e.g. a catheterwith electrolyte fluid. – EXCL8: the subject has a debridement intolerance (e.g. unacceptable pain). – EXCL9: the subject has a compression therapy intolerance (e.g. unacceptable pain). – EXCL10: the subject uses systemic antibiotics. – EXCL11: the subject is hospitalized at the time of inclusion or likely to be hospitalized in the near future (22 weeks). – EXCL12: the subject has had vascular surgery related to the to-be-treated wound within the previous 2 months. – EXCL13: the subject experienced an occurrence of deep vein thrombosis in the previous 3 months. – EXCL14: the subject has any known malignant wound degeneration. – EXCL15: 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. – EXCL16: 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. – EXCL17: the subject has uncontrolled diabetes mellitus* (HbA1c >10% (86 mmol/mol) within the previous 6 months; or unknown HbA1c). – Note: Patients with controlled diabetes mellitus (HbA1c<10% (86 mmol/mol) within the previous 6 months) can be enrolled. – Note 2: a subject may be enrolled if controlled diabetes is expected. Make sure to verify as soon as possible that HbA1c < 10% (86 mmol/mol), if not the subject had to be excluded. – EXCL18: the subject suffers from comorbidity or there are other circumstances (e.g. long lasting COVID-19 symptoms), which in the investigator's opinion, are likely to compromise the outcome of the study or the feasibility of the subject fulfilling the study. – EXCL19: the subject had a COVID-19 infection (i.e. tested positive for COVID-19 or very likely infected with COVID-19 but not confirmed by a COVID-19 test) in the past 6 months (counted from disease onset) and still has persistent symptoms (such as fatigue). – EXCL20: the subject has epilepsy. – EXCL21: the subject is pregnant – EXCL22: the subject does not (agree to) comply with the SOC. – EXCL23: the subject participates in another study. – EXCL24: the subject is unable to provide consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Plasmacure
  • Collaborator
    • European Commission
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Koen Lim, Study Director, Plasmacure
  • Overall Contact(s)
    • Maarten Hieltjes, +31 (0)618598711, maarten.hieltjes@plasmacure.nl

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