The PROTECT 2 Study : Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial

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Conditions studied: Stage 1 Pressure Ulcer, Stage 2 Pressure Ulcer

In brief

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.

Key facts

Study ID

NCT05085288

Run by

The Cleveland Clinic

People needed

1100

Starts

2022-02-08

Expected to finish

2026-12-01

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Wake Forest Unverisity — Winston-Salem, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Univeristy of Graz — Graz, Austria

Full record on ClinicalTrials.gov

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