PLASOMA Ultimate Safety & Efficacy Study (PULSE)

STATUS

Recruiting
End date

Dec 29, 2023
participants needed

100
sponsor

Plasmacure

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Updated on 4 October 2022

See if I qualify

wound care

NPUAP

healing ulcer

Summary

The purpose of the PULSE study are the followingL

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

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

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

Details

Condition	Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound, Skin Graft, Infected Surgical Wound, Skin Flap
Treatment	PLASOMA
Clinical Study Identifier	NCT04828304
Sponsor	Plasmacure
Last Modified on	4 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	INCL1: have a slow-healing or non-healing ulcer consisting of, but not limited
	to
	diabetic ulcers (Wagner-Meggitt classification system/ University of Texas classification system: grades 1-3)
	venous ulcers
	pressure ulcers (international NPUAP/EPUAP classification system: categories/stages II-IV)
	burn wounds (second and third degree)
	skin grafts and flaps
	infected post-surgical ulcers. Standard wound care has not resulted in sufficient healing after at least two weeks (including first line care) (Ref 25, Ref 26)
	Note: There is no upper limit for the duration that the wound exists. In case a subject has
	multiple wounds that meet the in- and exclusion criteria, the wound with the longest
	duration will be chosen for the study
	INCL2: have a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of
	5 cm (~16 cm2 wound surface area for circular wounds)
	INCL3: have a minimum age of 18 years old
	INCL4: for home care treatments only: have a grounded wall socket available for connection
	of PLASOMA
Exclusion Criteria
	EXCL1: the subject has one or more of the following contraindications for PLASOMA
	the wound is very exudative, i.e. wounds in which moisture is visible again within a
	few minutes after patting dry
	any implanted active electronic device, such as a pacemaker, is present
	an electronic medical device is attached to the body, including electronic life
	support equipment, hearing aids, glucose sensors and insulin pumps. If the sole
	purpose of the medical device is monitoring, the subject is not excluded, but it
	should be noted that use of PLASOMA together with such devices has not been tested and
	may lead to erroneous operation of the attached device during PLASOMA treatment
	Note: no exclusion if electronic medical device will be detached during PLASOMA
	treatment
	a metal implant (including a stent) is present in the treatment area, i.e. the area
	a conductive connection from outside to inside the body at or near the heart is
	between pad and electrode
	present, e.g. a catheter with electrolyte fluid
	the subject has epilepsy
	the subject is pregnant
	the to-be-treated wound is located on the torso above the navel
	EXCL2: the subject has any known malignant wound degeneration
	EXCL3: the subject receives treatment with immunosuppressive agents or oral
	corticosteroids; no exclusion if subject has received a stable dose for at least 2 months
	and the oral corticosteroid dose does not exceed 7.5 mg/day prednisone or equivalent
	EXCL4: the subject is receiving or likely to receive advanced wound therapies - such as
	negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes
	growth factors), electrophysical therapy - until FU1 for the to be-treated wound. Advanced
	wound dressings are not excluded
	EXCL5: the subject participates in another study which is likely to compromise the outcome
	of the PULSE study or the feasibility of the subject fulfilling the PULSE study
	EXCL6: the subject is unable to provide consent

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Step 4 Get your study results

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PLASOMA Ultimate Safety & Efficacy Study (PULSE)