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PLASOMA Efficacy & Technology Health (PETH) Study

NCT04922463 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-06-12

No results posted yet for this study

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

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

PLASOMA

Treatment with cold plasma device

Sponsors & Collaborators

Principal Investigators

  • Koen Lim · Plasmacure

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-04-20
Completion
2023-04-20

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04922463 on ClinicalTrials.gov