PLASOMA Ultimate Safety & Efficacy Study

NCT ID: NCT04828304

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-26
• Study Completion Date: 2024-12-16

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

treatment group

Standard of care + PLASOMA treatment

Group Type: EXPERIMENTAL

PLASOMA

Intervention Type: DEVICE

Treatment with cold plasma device

Interventions

PLASOMA

Treatment with cold plasma device

Intervention Type: DEVICE

Eligibility Criteria

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).

Exclusion Criteria

INCL2: have a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 4.5 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.

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 between pad and electrode.
• a conductive connection from outside to inside the body at or near the heart is 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diabetes Fonds

OTHER

Sponsor Role: collaborator

Pathology and Medical Microbiology

UNKNOWN

Sponsor Role: collaborator

Plasmacure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Koen Lim

Role: STUDY_DIRECTOR

Plasmacure

Locations

Groene Hart Ziekenhuis

Gouda, , Netherlands

Alrijne Ziekenhuis

Leiderdorp, , Netherlands

Sint Antonius Ziekenhuis

Nieuwegein, , Netherlands

radboud Universitair Medisch Centrum

Nijmegen, , Netherlands

Expertisecentrum Wondzorg (EcW)

Oosterhout, , Netherlands

Maxima Medisch Centrum (MMC)

Veldhoven, , Netherlands

Countries

Netherlands

Other Identifiers

PULSE study

Identifier Type: -

Identifier Source: org_study_id