PLASOMA Ultimate Safety & Efficacy Study

Not Applicable

Active, not recruiting

• Conditions: Pressure Ulcer; Skin Flap; Diabetic Foot Ulcer; Venous Leg Ulcer; Infected Surgical Wound; Burn Wound; Skin Graft
• Interventions: Device: PLASOMA

• Registration Number: NCT04828304
• Lead Sponsor: Plasmacure

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2021-05-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	PLASOMA	Standard of care + PLASOMA treatment

Primary Outcome Measures

Name	Time	Method
Safety PLASOMA - device related SAEs	12 months	device related SAEs
Efficacy PLASOMA - bacterial load reduction - Staphylococcus aureus	once at week 1 (wound swab directly before and after first PLASOMA treatment)	Reduction in number of S. aureus colonies, using wound swab and quantitative analysis
Efficacy PLASOMA - wound surface area reduction	12 weeks	Wound surface area reduction

Secondary Outcome Measures

Name	Time	Method
Efficacy PLASOMA - Ulcer recurrence	12 months	Ulcer recurrence
Safety PLASOMA - all AEs	12 months	Safety reporting
Safety PLASOMA - wound appearance	24 weeks	wound appearance
Efficacy PLASOMA - Bacterial load reduction	once at week 1 (wound swab directly before and after first PLASOMA treatment)	Bacterial load reduction (total load and Pseudomonas aeruginosa), using wound swab and semi-quantitative analysis
Efficacy PLASOMA - wound pain	12 weeks	wound pain (0-10 numerical rating scale)
Efficacy PLASOMA- wound healing	12 weeks	Wound healing - wound surface area reduction - wound volume reduction - time to healing
Efficacy PLASOMA - Quality of Life	14 weeks	Quality of Life, using Wound-QoL questionnaire
Efficacy PLASOMA - wound infection	12 weeks	wound infection (clinical classification)
Health Technology Assessment PLASOMA	12 weeks	resource usage PLASOMA
Patient acceptability	12 weeks	Patient acceptability (subjects will be asked if they are happy with the PLASOMA treatment)

Trial Locations

Locations (6)

Alrijne Ziekenhuis; 🇳🇱 Leiderdorp, Netherlands

radboud Universitair Medisch Centrum; 🇳🇱 Nijmegen, Netherlands

Expertisecentrum Wondzorg (EcW); 🇳🇱 Oosterhout, Netherlands

Sint Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Maxima Medisch Centrum (MMC); 🇳🇱 Veldhoven, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands