PLASOMA Efficacy & Technology Health (PETH) Study: A Post-market Randomised Controlled Efficacy Study of PLASOMA on Wound Healing in Chronic Venous Leg Ulcers
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
PLASOMA Ultimate Safety and Efficacy Study - PULSE study
PLASOMA Ultimate Safety & Efficacy Study
The purpose of the PULSE study are the followingL
A.To perform post market clinical follow up (PMCF) on safety and efficacy:
Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks.
Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area.
A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA).
This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands.
The two arms are:
Control group: Standard wound care for 12 weeks or until healing, whichever occurs first;
Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first.
The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site.
For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day.
Follow up (FU) will be performed at three timepoints for both arms:
FU1: 2 weeks after end treatment period
FU2: 12 weeks after end treatment period
FU3: 12 months after start treatment.
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