PLASOMA Efficacy & Technology Health study. A post-market randomised controlled efficacy study of PLASOMA on wound healing in chronic venous leg ulcers.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

INCL1: have a slow-healing or non-healing lower leg ulcer presumed to be
caused by venous insufficiency (VLU). The wound should have insufficient
healing (<30% surface area reduction) during the last 2 weeks of standard
wound care.
INCL2: have a wound with a minimum wound surface area of 0.5 cm2 and
a maximum diameter of 6 cm (~28 cm2 wound surface area for circular
wounds).
INCL3: have an Ankle Brachial Pressure Index (ABPI) between 0.8 and 1.3.
Note 1: subject can be included based on a VLU diagnosis from
anamnesis. Make sure an ABPI measurement is performed as soon as
possible to verify the diagnosis. The subject has to be excluded if the
ABPI is not between 0.8 and 1.3.
Note 2: For diabetic patients an ABPI measurement is not always reliable.
Therefore, diabetic patients can be included based on a VLU diagnosis
from anamnesis, but no ABPI measurement needs to be performed.
INCL4: have a minimum age of 18 years old.
INCL5: For home care treatments only: there is 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
EXCL2: the subject uses systemic antibiotics.
EXCL3: the subject has any known malignant wound degeneration.
EXCL4: 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.
EXCL5: the subject is receiving or likely to receive advanced wound
dressings or advanced therapies- such as negative pressure therapy,
hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth
factors), electrophysical therapy - for the to-be-treated wound.
EXCL6: the subject cannot (agree to) comply with the SOC.
EXCL7: the subject participates in another study which is likely to
compromise the outcome of the PETH study or the feasibility of the
subject fulfilling the PETH study.
EXCL8: the subject is unable to provide consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Evaluate the percentage of wounds healed after 12 weeks of treatment with<br /><br>PLASOMA for two treatment frequencies: once per week and twice per week.<br /><br><br /><br>This will be done by comparing the treatment groups with the control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluate the effect and safety of PLASOMA by assessing:<br /><br><br /><br>• % Wound healing after 4 weeks<br /><br>• Time to healing (until 12 weeks)<br /><br>• % Wounds with wound surface area reduction >=50% after 4 weeks of treatment<br /><br>• % Wound surface area reduction after 4 and 12 weeks of treatment<br /><br>• % Wound volume reduction after 4 and 12 weeks of treatment<br /><br>• Number of recurrences at 5, 9 and 12 weeks after end treatment period<br /><br>• Scarring at FU1 and FU2<br /><br>• Quality of life: RAND-36 (general) and Wound-QOL (wound specific)<br /><br>• Wound pain during treatment period<br /><br>• Wound infection<br /><br>• Resources involved (input for Health Technology Assessment)<br /><br>• Patient acceptability during treatment period<br /><br>• Adverse Events with a potential relation to PLASOMA<br /><br><br /><br><br /><br>This will be done by comparing the treatment groups with the control group.</p><br>