PLASOMA Efficacy & Technology Health (PETH) Study

Status Terminated

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04922463
Study type	Interventional
Source	Plasmacure
Contact
Status	Terminated
Phase	N/A
Start date	June 1, 2021
Completion date	April 20, 2023

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See also
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