NCT04922463

PLASOMA Efficacy & Technology Health (PETH) Study

PLASOMA Efficacy & Technology Health (PETH) Study: A Post-market Randomised Controlled Efficacy Study of PLASOMA on Wound Healing in Chronic Venous Leg Ulcers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Plasmacure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	PLASOMA	Treatment with cold plasma device

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2021-06-10
• Last updated: 2024-06-12

Locations

2 sites across 1 country: Netherlands