Trials Sponsors Conditions Drugs Pricing

Conditions

Stage 1 Pressure Ulcer Stage 2 Pressure Ulcer

Outcome Measures

Primary Outcomes (2)

Efficacy of adding the IES System to standard of care
Investigators will assess the IES System to determine the efficacy of an IES system after being added to the standard of care on the primary outcome of sacral and ischial pressure injury score measured over time.
24 hours of admission to the ICU or non-ICU hospital service
Compare using the IES oppose to only standard care
Investigators will assess time to resolution of the ulcer
24 hours of admission to the ICU or non-ICU hospital service

Secondary Outcomes (2)

Compare IES to standard care
24 hours of admission to the ICU or non-ICU hospital service
Evaluate treatment effect heterogeneity across levels of the following patient factors
24 hours of admission to the ICU or non-ICU hospital service until discharged

Study Arms (2)

Intermittent electrical stimulation system (IES) treatment Group

ACTIVE COMPARATOR

Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10 seconds every 10 minutes.

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

Standard of care Group

ACTIVE COMPARATOR

Standard inpatient nursing practice for wound care, wound care prevention, and any other wound care or plastic surgery treatments deemed appropriate as per usual care.

Other: Turning population every two hours

Interventions

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

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.

Intermittent electrical stimulation system (IES) treatment Group

Turning population every two hoursOther

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

The Cleveland Clinic
Otherlead

Study Sites (3)

Wake Forest Unverisity

Winston-Salem, North Carolina, 27109, United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Univeristy of Graz

Graz, A-8010, Austria

Related Publications (1)

Donaldson C, de Abreu MG, Mascha EJ, Rowbottom J, Harvester E, Khanna A, Sura T, Sessler DI, Patarroyo FR, Gulluoglu A, Zajic P, Chauhan U, Essber H, Kurz A. Pressure injury treatment by intermittent electrical stimulation (PROTECT-2): protocol for a multicenter randomized clinical trial. Trials. 2024 May 10;25(1):313. doi: 10.1186/s13063-024-08085-x.
PMID: 38730383DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Chase Donaldson, MD
The Cleveland Clinic
PRINCIPAL INVESTIGATOR
Andrea Kurz, MD
The Cleveland Clinic
STUDY CHAIR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 20, 2021

Study Start

February 8, 2022

Actual (reported)

Primary Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

Intermittent electrical stimulation system (IES) treatment Group

Standard of care Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

Intermittent electrical stimulation system (IES) treatment Group

Standard of care Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations