PLASOMA Efficacy & Technology Health (PETH) Study
- Conditions
- Venous Leg Ulcer
- Interventions
- Device: PLASOMA
- Registration Number
- NCT04922463
- Lead Sponsor
- Plasmacure
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1x PLASOMA PLASOMA - 2x PLASOMA PLASOMA -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of recurrences 12 weeks Wound healing 4 weeks Time to healing until 12 weeks Wound volume reduction 12 weeks Scarring FU2 (12 weeks after end of treatment) Quality of life - general FU1 (2 weeks after end of treatment) RAND-36 questionnaire
% Wounds with wound surface area reduction ≥50% 4 weeks Wound surface area reduction 12 weeks Quality of life - wound specific FU1 (2 weeks after end of treatment) Wound-QOL questionnaire
Wound pain 20 weeks wound pain, using 0-10 numerical rating scale
Wound infection until FU2 (12 weeks after end of treatment) wound infection (clinical classification)
Health Technology Assessment 20 weeks resources used
Patient acceptability 20 weeks subjects will be asked if they are happy with the PLASOMA treatment
Adverse Events with a potential relation to PLASOMA 20 weeks
Trial Locations
- Locations (2)
BBeterzorg
🇳🇱Sittard, Netherlands
Thebe Zorg Thuis
🇳🇱Tilburg, Netherlands