PLASOMA Ultimate Safety & Efficacy Study (PULSE)

  • End date
    Dec 29, 2023
  • participants needed
  • sponsor
Updated on 4 October 2022
wound care
healing ulcer


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.

Condition Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound, Skin Graft, Infected Surgical Wound, Skin Flap
Treatment PLASOMA
Clinical Study IdentifierNCT04828304
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

INCL1: have a slow-healing or non-healing ulcer consisting of, but not limited
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

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note