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

NCT05085288 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Stage 1 Pressure Ulcer
  • Stage 2 Pressure Ulcer

Interventions

DEVICE

Intermittent electrical stimulation system (IES) treatment and turning patient every two hours

The investigators propose to assess whether addition of the IES system and the use of standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries by decreasing progression of stage 1 and stage 2 ulcers or facilitates their healing compared to standard wound care in an inpatient critical care population.

OTHER

Turning population every two hours

The investigators propose to assess whether current standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Chase Donaldson, MD · The Cleveland Clinic

  • Andrea Kurz, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085288 on ClinicalTrials.gov