Status:
COMPLETED
PLASOMA Ultimate Safety & Efficacy Study
Lead Sponsor:
Plasmacure
Collaborating Sponsors:
Diabetes Fonds
Pathology and Medical Microbiology
Conditions:
Diabetic Foot Ulcer
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- INCL1: have a slow-healing or non-healing ulcer consisting of, but not limited to:
- 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 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.
Exclusion
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04828304
Start Date
May 26 2021
End Date
December 16 2024
Last Update
June 3 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Groene Hart Ziekenhuis
Gouda, Netherlands
2
Alrijne Ziekenhuis
Leiderdorp, Netherlands
3
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
4
radboud Universitair Medisch Centrum
Nijmegen, Netherlands