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

Description

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.

Conditions

Stage 1 Pressure Ulcer, Stage 2 Pressure Ulcer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Stage 1 Pressure Ulcer
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest Unverisity, Winston-Salem, North Carolina, United States, 27109

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Chase Donaldson, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Andrea Kurz, MD, STUDY_CHAIR, The Cleveland Clinic

Study Record Dates

2025-01