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 range18 Years

SexALL

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

What they're measuring

Efficacy of adding the IES System to standard of care

Timeframe: 24 hours of admission to the ICU or non-ICU hospital service

Compare using the IES oppose to only standard care

Timeframe: 24 hours of admission to the ICU or non-ICU hospital service

Trial details

NCT IDNCT05085288

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Stage 1 Pressure Ulcer trials