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

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Stage 1 Pressure Ulcer; Stage 2 Pressure Ulcer

Treatments: Device: Intermittent electrical stimulation system (IES) treatment and turning patient every two hours; Other: Turning population every two hours

Study type: Interventional

Funder types: Other

Identifiers

NCT05085288

21-1009

Details and patient eligibility

About

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.

Full description

This is a two-arm, prospective randomized control trial assessing whether IES combined with the standard of care (treatment) is superior to the standard of care alone (control). The study is a parallel design, adaptive, non-blinded randomized controlled trial, and uses two-sided analysis. We plan interim analyses at each 25% of the N. Part of the early interim analyses (first and second) will involve reassessing the a priori assumptions on data distributions and variability use in sample size calculations and updating the study size needed. Treatment effect results will be shared with the Data Safety Monitoring Board (DSMB) to determine whether the study should be ended early for either futility or having demonstrated superiority of the intervention. Patients can be entered into the protocol multiple times with independent assessments of inclusion/exclusion criteria and new consent for each enrollment. At each enrollment they will be re-randomized to either experimental or control arm. For the purpose of overall survival analysis (the only endpoint with a delayed assessment of outcome), such patients will be excluded.

This trial studies adult inpatients in both ICU and non-ICU environments with either new or established stage 1 or stage 2 sacral and ischial pressure injuries. Patients with a pacemaker/AICD, rhabdomyolysis, gluteal skin breakdown, and unstable fractures at risk of displacement by IES are excluded. Patients with atrial or ventricular wires after cardiac surgery can be enrolled as long as they are not being paced or in the opinion of the treating physician are at high risk of requiring pacing.

Subjects will be assessed for pressure injury status from point of randomization to discharge, death, or a minimum of 30 days. Device utilization and data collection can stop after 14 days in a non-ICU environment or when a total of 30 days of data collection has been met. If subjects are in the ICU longer than 30 days or when the combined total of ICU and less than 14 non-ICU days is greater than 30 days, the assessment and use of the device may continue after 30 days. Following entry into the study, participants will receive either the IES device in addition to the standard of care (treatment group) or the standard of care alone (control group). The study is expected to complete accrual within 12-18 months. Participant treatment will occur for the same amount of time as pressure injury assessment occurs as described above.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,100 participants in 2 patient groups

Intermittent electrical stimulation system (IES) treatment Group

Active Comparator group

Description:

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

Treatment:

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

Standard of care Group

Active Comparator group

Description:

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.

Treatment:

Other: Turning population every two hours