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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Treatment with cold plasma device
BBeterzorg
Sittard, Netherlands
Thebe Zorg Thuis
Tilburg, Netherlands
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
Wound healing
Time frame: 4 weeks
Time to healing
Time frame: until 12 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 volume reduction
Time frame: 4 weeks
Wound volume reduction
Time frame: 12 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
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Time frame: FU2 (12 weeks after end of treatment)
Quality of life - general
RAND-36 questionnaire
Time frame: FU1 (2 weeks after end of treatment)
Quality of life - wound specific
Wound-QOL questionnaire
Time frame: FU1 (2 weeks after end of treatment)
Wound pain
wound pain, using 0-10 numerical rating scale
Time frame: 20 weeks
Wound infection
wound infection (clinical classification)
Time frame: until FU2 (12 weeks after end of treatment)
Health Technology Assessment
resources used
Time frame: 20 weeks
Patient acceptability
subjects will be asked if they are happy with the PLASOMA treatment
Time frame: 20 weeks
Adverse Events with a potential relation to PLASOMA
Time frame: 20 weeks