PLASOMA Ultimate Safety and Efficacy Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

INCL1: have a slow-healing or non-healing ulcer consisting of, but not limited
to diabetic ulcers, venous ulcers, pressure ulcers, burn wounds, skin grafts
and flaps and infected post-surgical ulcers.
Standard wound care has not resulted in sufficient healing after at least two
weeks (including first line care).
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 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.

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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objectives/outcomes of this study:<br /><br>1. To evaluate the safety of the PLASOMA by analysing the number and type of<br /><br>device related SAEs, including long term (12 months) follow up.<br /><br>2. To evaluate* the efficacy of the PLASOMA by measuring the reduction in<br /><br>number of Staphylococcus aureus colonies. This will be done during the frist<br /><br>treatment only.<br /><br>3. To evaluate* the efficacy of the PLASOMA by measuring the % wound surface<br /><br>area reduction after 12 weeks of treatment.<br /><br><br /><br>*) This will be done by comparing the treatment group with the control group.</p><br>

Secondary Outcome Measures