Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-02 @ 2:55 PM
Study NCT ID:
NCT04828304
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PLASOMA Ultimate Safety & Efficacy Study
Sponsor:
Plasmacure
Organization:
Study Overview
Official Title:
PLASOMA Ultimate Safety & Efficacy Study
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PULSE
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: