Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

Part of paid clinical trials in Fort Sam Houston, Texas.

Sponsor
The Metis Foundation
Study ID
NCT06921421
Status
Not Yet Recruiting

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Conditions

  • Burn
  • Burn Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spatial Frequency Domain Imaging — DIAGNOSTIC_TEST
    Spatial Frequency Domain Imaging captures at specific timepoints.

Study Details

The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).

Key Dates

Start date
Apr 30, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
15 participants (estimated)

Primary Outcome Measure

Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems [ Time Frame: From enrollment to 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The United States Army Institute of Surgical ResarchFort Sam HoustonTexas78234
Kristin Anselmo
[email protected]
2105691138

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The United States Army Institute of Surgical Resarch· Fort Sam Houston, TX

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