RECRUITING

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

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Conditions

Stage 1 Pressure UlcerStage 2 Pressure Ulcer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-02-08
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05085288

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Either new or established stage 1 or 2 sacral or ischial pressure ulcer in the ICU or non-ICU environments.
  2. * Participants capable of giving informed consent, or if propitiate, participants having an acceptable individual capable of giving consent on the participant's behalf.
  1. * Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction.
  2. * Rhabdomyolysis
  3. * 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.
  4. * Skin breakdown or malignant skin involvement over the gluteal regions that would preclude the use of surface electrodes
  5. * BMI \> 40

Contacts and Locations

Study Contact

Fabio Rodriguez
CONTACT
216-444-9950
RODRIGF3@ccf.org
Fabio Rodriguez, MD
CONTACT
216-444-9950
RODRIGF3@ccf.org

Principal Investigator

Chase Donaldson, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Andrea Kurz, MD
STUDY_CHAIR
The Cleveland Clinic

Study Locations (Sites)

Wake Forest Unverisity
Winston-Salem, North Carolina, 27109
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Chase Donaldson, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
  • Andrea Kurz, MD, STUDY_CHAIR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-08
Study Completion Date2025-01

Study Record Updates

Study Start Date2022-02-08
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Stage 1 Pressure Ulcer
  • Stage 2 Pressure Ulcer