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Active, not recruiting Phase 2 Interventional Accepts healthy volunteers Results available

Skin Change Actions by Nursing

ClinicalTrials.gov ID: NCT06127524

Public ClinicalTrials.gov record NCT06127524. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT06127524
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
4,733 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 3, 2022
Primary completion
Feb 21, 2025
Completion
Jun 29, 2026
Last update posted
Jun 11, 2026

2022 – 2026

United States locations

U.S. sites
7
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Large proprietary nursing home chain faciity #3 Kennett Square Pennsylvania 19348
Large proprietary nursing home chain facility #1 Kennett Square Pennsylvania 19348
Large proprietary nursing home chain facility #4 Kennett Square Pennsylvania 19348
Large proprietary nursing home chain facility #5 Kennett Square Pennsylvania 19348
Large proprietary nursing home chain facility #6 Kennett Square Pennsylvania 19348
Large proprietary nursing home chain facility #7 Kennett Square Pennsylvania 19348
Large proprietary nursing home chain facilty #2 Kennett Square Pennsylvania 19348

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06127524, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 11, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06127524 live on ClinicalTrials.gov.

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