The PROTECT 2 Study : Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomi… (NCT05085288) | Clinical Trial Compass
SuspendedNot Applicable
The PROTECT 2 Study : Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial
Stopped: Study is on administrative enrollment hold.
United States, Austria1,100 participantsStarted 2022-02-08
Plain-language summary
Multicentered randomized controlled study with adaptive design to evaluate if Intermittent Electrical Stimulation (IES) decreases progression and facilitates healing of pressure injuries for patients with, sacral / ischial pressure injuries.
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:
* Either new or established stage 1 or 2 sacral or ischial pressure ulcer in the ICU or non-ICU environments.
* Participants capable of giving informed consent, or if propitiate, participants having an acceptable individual capable of giving consent on the participant's behalf.
Exclusion Criteria:
* Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction.
* Rhabdomyolysis
* Presence of permanent pacemaker or AICD, and for those with external wires after cardiac surgery, those who are using or at high risk for the development of a requirement for an external pacemaker.
* Skin breakdown or malignant skin involvement over the gluteal regions that would preclude the use of surface electrodes
* BMI \> 40
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.
What they're measuring
1
Efficacy of adding the IES System to standard of care
Timeframe: 24 hours of admission to the ICU or non-ICU hospital service
2
Compare using the IES oppose to only standard care
Timeframe: 24 hours of admission to the ICU or non-ICU hospital service