chronic wound - venous leg ulcer
Conditions
Interventions
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
Sponsors
Plasmacure B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 (
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed