Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Burn; Burn Injury
• Intervention / Treatment: Diagnostic test: Spatial Frequency Domain Imaging

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Victoria Diaz, BSN; Phone Number: 210-201-2206; Email: diaz@metisfoundationusa.org

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • The United States Army Institute of Surgical Resarch
      • Contact: Kristin Anselmo; Phone Number: 2105691138; Email: kanselmo@metisfoundationusa.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients receiving care at the US Army Institute of Surgical Research (USAISR) Burn Center with thermal burn injuries will be considered for enrollment into this study

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients less than 18 years of age
2. Pregnant or breastfeeding women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems	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.	From enrollment to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth	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).	From enrollment to 21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement Between Clarifi and m-Clarifi Devices in Measuring SFDI Scattering Parameter	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).	From enrollment to 21 days

Collaborators and Investigators

• Sponsor: The Metis Foundation
• Collaborators: Modulated Imaging Inc.; The United States Institute of Surgical Research
• Investigators: Principal Investigator: Rodney Chan, MD, The Metis Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: SFDI; Spatial Frequency Domain Imaging; Burn depth; Burn injury assessment
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: H-25-017; MTEC-22-08-BDA-007 (Other Grant/Funding Number: Medical Technology Enterprise Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No