This study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad.The intention is that the data obtained with this study…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluate the percentage of wounds healed after 12 weeks of treatment with
PLASOMA for two treatment frequencies: once per week and twice per week.
This will be done by comparing the treatment groups with the control group.
Secondary outcome
Evaluate the effect and safety of PLASOMA by assessing:
• % Wound healing after 4 weeks
• Time to healing (until 12 weeks)
• % Wounds with wound surface area reduction >=50% after 4 weeks of treatment
• % Wound surface area reduction after 4 and 12 weeks of treatment
• % Wound volume reduction after 4 and 12 weeks of treatment
• Number of recurrences at 5, 9 and 12 weeks after end treatment period
• Scarring at FU1 and FU2
• Quality of life: RAND-36 (general) and Wound-QOL (wound specific)
• Wound pain during treatment period
• Wound infection
• Resources involved (input for Health Technology Assessment)
• Patient acceptability during treatment period
• Adverse Events with a potential relation to PLASOMA
This will be done by comparing the treatment groups with the control group.
Background summary
Safety and efficacy (positive effect on bacterial load) of PLASOMA has
previously been demonstrated on 20 patients with diabetic foot wounds, in a
1-arm clinical trial with a follow-up period of 3 months.
This post market study is a follow-up to a previous clinical study on diabetic
foot wounds used to obtain CE marking and an addition to another post market
study that aims to confirm safety and efficacy in a larger and more diverse
population (50% diabetic foot wounds, 50% other chronic wounds) with long-term
safety monitoring. The aim of this post market study is to investigate the
efficacy of PLASOMA on wound healing in a group of patients with venous leg
ulcers (VLUs).
Study objective
This study is designed to examine beneficial effects of PLASOMA treatment
compared to the standard of care on chronic venous leg ulcers (VLU) that match
the size of the plasma area of the pad.
The intention is that the data obtained with this study will be used to:
1. Demonstrate comparative performance of PLASOMA (for two treatment
frequencies)
2. Provide evidence for health technology assessments (HTA) of PLASOMA
Study design
The PETH study will be an open label three-armed randomized controlled trial
(RCT) on chronic VLU. The study will be performed at one study site in the
Netherlands.
The three arms are:
• Control group: standard care for 12 weeks or until healing, whichever occurs
first;
• Treatment group-1: standard care + PLASOMA treatment once per week for 12
weeks or until healing, whichever occurs first;
• Treatment group-2: standard care + PLASOMA treatment twice per week for 12
weeks or until healing, whichever occurs first.
After the treatment period there will be two follow up timepoints: 2 weeks
after the end of the treatment period (FU1) and 12 weeks after the end of the
treatment period (FU2).
Subjects will be allocated to one of the three arms according to a pre-defined
randomization schedule.
Intervention
After cleaning the wound, a (para)medical professional applies a PLASOMA
treatment of two minutes.
The PLASOMA treatment takes maximum 12 weeks with a treatment frequency of once
per week for the first two arms and a frequency of twice per week for the third
arm (treatment group-2).
Study burden and risks
Subjects will be treated with cold plasma for 2 minutes. The treatment takes
maximum 12 weeks with a treatment frequency of once per week or twice per week
(depending on the study arm). After the treatment period there are two follow
up moments: 2 and 12 weeks after the end of the treatment. On top of this the
following additional contact moments can be needed:
A. When the wound is healed within the treatment period, the subject will be
contacted twice by telephone to see if the wound did not re-open. This will be
done at 5 and 9 weeks after the end of the treatment period..
B. When the wound is not healed within the treatment period, but is healed
within 12 weeks after the end of the treatment period, a (home) visit will take
place when the wound is healed and two weeks after healing.
At the start of the study, questions about the current medical situation and
medical history will be asked. Subjects are asked to fill in three
questionnaires (at the start of the study and after the treatment period).
Risks include mild, local and transient sensations during or shortly after
treatment. Very commonly tingling, warmth or other mild sensations are felt;
slight pain can also be felt.
PLASOMA treatment can possibly improve the treatment of chronic wound, this
could reduce complications in the future. Risks for the participating subjects
are limited and comparable interventions have been shown in previous studies to
be safe. That is why we believe it is justified to investigate the safety and
efficacy of PLASOMA in subjects with chronic wounds.
High Tech Campus 12
Eindhoven 5656 AE
NL
High Tech Campus 12
Eindhoven 5656 AE
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76826.015.22 |