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NCT Number: NCT06921421

Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

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).

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Key information

Conditions

Burn Burn Injury Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The United States Army Institute of Surgical Resarch

Fort Sam Houston, Texas, 78234, United States

Location contact

Kristin Anselmo

CONTACT

[email protected]

2105691138

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older
  • Thermal burns of any depth (superficial, deep partial thickness, or full thickness).

Exclusion criteria

  • Patients less than 18 years of age
  • Pregnant or breastfeeding women

Treatment and study plan

Spatial Frequency Domain Imaging

Diagnostic Test

Spatial Frequency Domain Imaging captures at specific timepoints.

Primary outcomes

  1. Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems

    Time frame: From enrollment to 21 days

    This outcome will report the mean value of the scattering coefficient (μs'), a quantitative SFDI-derived biomarker that correlates with burn depth, measured at specified time points (Day 0, 3, 7, 14, and 21) using the Clarifi and m-Clarifi imaging systems. Higher scattering values are associated with deeper tissue damage.

Secondary outcomes

  1. Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth

    Time frame: From enrollment to 21 days

    This outcome evaluates the statistical correlation between SFDI scattering values and the burn depth classifications made by clinicians based on visual assessment and standard clinical criteria (e.g., superficial partial, deep partial, full thickness).

Other outcomes

  1. Agreement Between Clarifi and m-Clarifi Devices in Measuring SFDI Scattering Parameter

    Time frame: From enrollment to 21 days

    This outcome assesses the agreement between SFDI scattering measurements obtained from the Clarifi (FDA-cleared) and m-Clarifi (handheld prototype) devices at the same anatomical burn sites. Agreement will be quantified using Bland-Altman analysis and intraclass correlation coefficients (ICCs).

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria Diaz, BSN

CONTACT

[email protected]

210-201-2206

Sponsors and collaborators

Lead sponsor

The Metis Foundation

Other

Collaborators

  • Modulated Imaging Inc.
  • United States Army Institute of Surgical Research

Registry information

Official study title

Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging (SFDI): An Observational Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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