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PLASOMA Ultimate Safety & Efficacy Study

NCT04828304 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-06-03

No results posted yet for this study

Summary

The purpose of the PULSE study are the followingL

A.To perform post market clinical follow up (PMCF) on safety and efficacy:

1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks.
2. 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:

1. Control group: Standard wound care for 12 weeks or until healing, whichever occurs first;
2. 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.

Conditions

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer
  • Pressure Ulcer
  • Burn Wound
  • Skin Graft
  • Infected Surgical Wound
  • Skin Flap

Interventions

DEVICE

PLASOMA

Treatment with cold plasma device

Sponsors & Collaborators

  • Diabetes Fonds

    collaborator OTHER

  • Pathology and Medical Microbiology

    collaborator UNKNOWN

  • Plasmacure

    lead INDUSTRY

Principal Investigators

  • Koen Lim · Plasmacure

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2024-12-16
Completion
2024-12-16

Countries

  • Netherlands

Study Locations

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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 NCT04828304 on ClinicalTrials.gov