PLASOMA Efficacy & Technology Health (PETH) Study

NCT04922463 | Terminated

• 1 other identifier: PETH study
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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

Study Arms (3)

Control group

NO INTERVENTION

1x PLASOMA

EXPERIMENTAL

Device: PLASOMA

2x PLASOMA

EXPERIMENTAL

Device: PLASOMA

Interventions

PLASOMA DEVICE

Treatment with cold plasma device

1x PLASOMA; 2x PLASOMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Plasmacure: lead
• European Commission: collaborator

Study Sites (2)

BBeterzorg

Sittard, 6135KD, Netherlands

Location

Thebe Zorg Thuis

Tilburg, 5042 DA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38687339 RESULT

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Koen Lim

  Plasmacure

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 10, 2021
• Study Start: June 1, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

NL (2)