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PLASOMA Efficacy & Technology Health (PETH) Study

Primary Purpose

Venous Leg Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PLASOMA
Sponsored by
Plasmacure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • BBeterzorgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

1x PLASOMA

2x PLASOMA

Arm Description

Outcomes

Primary Outcome 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

Secondary Outcome Measures

Wound healing
Time to healing
% Wounds with wound surface area reduction ≥50%
Wound surface area reduction
Wound surface area reduction
Wound volume reduction
Wound volume reduction
Number of recurrences
Number of recurrences
Number of recurrences
Scarring
Scarring
Quality of life - general
RAND-36 questionnaire
Quality of life - wound specific
Wound-QOL questionnaire
Wound pain
wound pain, using 0-10 numerical rating scale
Wound infection
wound infection (clinical classification)
Health Technology Assessment
resources used
Patient acceptability
subjects will be asked if they are happy with the PLASOMA treatment
Adverse Events with a potential relation to PLASOMA

Full Information

First Posted
May 27, 2021
Last Updated
June 29, 2022
Sponsor
Plasmacure
Collaborators
European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT04922463
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Plasmacure
Collaborators
European Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Demonstrate comparative performance of PLASOMA (for two treatment frequencies) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
1x PLASOMA
Arm Type
Experimental
Arm Title
2x PLASOMA
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PLASOMA
Intervention Description
Treatment with cold plasma device
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Wound healing
Time Frame
4 weeks
Title
Time to healing
Time Frame
until 12 weeks
Title
% Wounds with wound surface area reduction ≥50%
Time Frame
4 weeks
Title
Wound surface area reduction
Time Frame
4 weeks
Title
Wound surface area reduction
Time Frame
12 weeks
Title
Wound volume reduction
Time Frame
4 weeks
Title
Wound volume reduction
Time Frame
12 weeks
Title
Number of recurrences
Time Frame
5 weeks
Title
Number of recurrences
Time Frame
9 weeks
Title
Number of recurrences
Time Frame
12 weeks
Title
Scarring
Time Frame
FU1 (2 weeks after end of treatment)
Title
Scarring
Time Frame
FU2 (12 weeks after end of treatment)
Title
Quality of life - general
Description
RAND-36 questionnaire
Time Frame
FU1 (2 weeks after end of treatment)
Title
Quality of life - wound specific
Description
Wound-QOL questionnaire
Time Frame
FU1 (2 weeks after end of treatment)
Title
Wound pain
Description
wound pain, using 0-10 numerical rating scale
Time Frame
20 weeks
Title
Wound infection
Description
wound infection (clinical classification)
Time Frame
until FU2 (12 weeks after end of treatment)
Title
Health Technology Assessment
Description
resources used
Time Frame
20 weeks
Title
Patient acceptability
Description
subjects will be asked if they are happy with the PLASOMA treatment
Time Frame
20 weeks
Title
Adverse Events with a potential relation to PLASOMA
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maarten Hieltjes
Phone
+31 (0)618598711
Email
maarten.hieltjes@plasmacure.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koen Lim
Organizational Affiliation
Plasmacure
Official's Role
Study Director
Facility Information:
Facility Name
BBeterzorg
City
Sittard
ZIP/Postal Code
6135KD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Quaaden
Phone
0031850645117
Email
melissa.quaaden@zuyderlandthuiszorg.nl
First Name & Middle Initial & Last Name & Degree
Chantal van Weersch
Phone
0031850645117
Email
chantal.vanweersch@zuyderlandthuiszorg.nl
First Name & Middle Initial & Last Name & Degree
Joost Van der Kleij
First Name & Middle Initial & Last Name & Degree
Melissa Quaaden
First Name & Middle Initial & Last Name & Degree
Chantal van Weersch

12. IPD Sharing Statement

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PLASOMA Efficacy & Technology Health (PETH) Study

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