CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 4,733 enrolled / 4,733 target
Drug / intervention
SEM Scannerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06127524
NCT06127524Phase 2ActiveUpdate Overdue (110.3/mo)Completion was 16mo ago

Biophysical Detection of Skin Changes to Cue Pressure Injury Prevention in Nursing Homes

University of California, Los Angeles·interventional·Posted Nov 13, 2023·Updated Jun 12, 2026

In Brief

A Phase 2 clinical trial evaluating SEM Scanner for Pressure Injury. Active but no longer recruiting, targeting 4,733 participants across 7 sites.

Signals

Enrollment appears stalled

Detailed Summary

Pressure injuries, local areas of damage to the skin and underlying soft tissue that are costly and painful, are often preventable with timely use of prevention strategies. Identifying early pressure induced tissue damage among nursing home residents by nursing staff during routine skin assessment is critical for this process. Finding early damage can prompt nursing home staff to start prevention actions and may allow viable tissue rescue, reducing other health problems or death. We propose use of sub-epidermal moisture (SEM) measures as the cue for nursing home staff to start prevention care. SEM provides early detection of skin damage by as much as 5 to 10 days prior to other methods, eliminates the inherent structural bias in visual skin assessment for residents with dark skin tones, and demonstrates a model of care using technology innovation in poorly-resourced healthcare settings to provide bedside, real-time, point-of-care feedback that is can be used immediately by nursing staff. In this study, nursing staff will use a device (the Provizio SEM Scanner) as part of standard skin assessments. The staff will use the values from the Provizio SEM Scanner during these assessments to decide if residents need preventive care for their skin. The study will look at these decisions and residents' subsequent health outcomes. The study will also use information about residents' skin health and prevention actions during the 52 weeks before the study as a comparison.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPressure Injury
CountriesUnited States

Timeline

Phase 2ActiveOverdue
2023202420252026
First PostedNov 13, 2023
Enrollment StartDec 4, 2022
Primary CompletionFeb 22, 2025
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 2.6 years ago

Arms & Interventions

Nursing Home Residents in interventionexperimental

All Nursing Home residents in the facility during the 8 month intervention period

Device: SEM Scanner
Nursing Home Residents in baselineno_intervention

All Nursing Home residents in the facility during the 12 month baseline period

Interventions

SEM Scannerdevice

Implementation of the SEM Scanner as part of weekly standard skin assessments of sacrum and heels