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-term/outstanding risks.
2. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area.
A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA).
This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands.
The two arms are:
1. Control group: Standard wound care for 12 weeks or until healing, whichever occurs first;
2. Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first.
The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site.
For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day.
Follow up (FU) will be performed at three timepoints for both arms:
* FU1: 2 weeks after end treatment period
* FU2: 12 weeks after end treatment period
* FU3: 12 months after start treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.