Clinical trial NCT04922463: PLASOMA Efficacy & Technology Health (PETH) Study
Official title: 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: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Plasmacure
Sponsor class: INDUSTRY
Collaborators: name: European Commission
First posted: 2021-06-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 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

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the percentage of wounds healed after 12 weeks of treatment with PLASOMA for two treatment frequencies: once per week and twice per week
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound healing
timeFrame: 4 weeks
measure: Time to healing
timeFrame: until 12 weeks
measure: % Wounds with wound surface area reduction ≥50%
timeFrame: 4 weeks
measure: Wound surface area reduction
timeFrame: 4 weeks
measure: Wound surface area reduction
timeFrame: 12 weeks
measure: Wound volume reduction
timeFrame: 4 weeks
measure: Wound volume reduction
timeFrame: 12 weeks
measure: Number of recurrences
timeFrame: 5 weeks
measure: Number of recurrences
timeFrame: 9 weeks
measure: Number of recurrences
timeFrame: 12 weeks
measure: Scarring
timeFrame: FU1 (2 weeks after end of treatment)
measure: Scarring
timeFrame: FU2 (12 weeks after end of treatment)
measure: Quality of life - general
timeFrame: FU1 (2 weeks after end of treatment)
measure: Quality of life - wound specific
timeFrame: FU1 (2 weeks after end of treatment)
measure: Wound pain
timeFrame: 20 weeks
measure: Wound infection
timeFrame: until FU2 (12 weeks after end of treatment)
measure: Health Technology Assessment
timeFrame: 20 weeks
measure: Patient acceptability
timeFrame: 20 weeks
measure: Adverse Events with a potential relation to PLASOMA
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: BBeterzorg
city: Tilburg
country: Netherlands
facility: Thebe Zorg Thuis
Study officials:
affiliation: Plasmacure
name: Koen Lim
role: STUDY_DIRECTOR
References:
citation: Bakker O, Smits P, van Weersch C, Quaaden M, Bruls E, van Loon A, van der Kleij J. Improved Wound Healing by Direct Cold Atmospheric Plasma Once or Twice a Week: A Randomized Controlled Trial on Chronic Venous Leg Ulcers. Adv Wound Care (New Rochelle). 2025 Jan;14(1):1-13. doi: 10.1089/wound.2023.0196. Epub 2024 Jun 3.