Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

NCT06921421 | Not Yet Recruiting

• 2 other identifiers: H-25-017MTEC-22-08-BDA-007
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Burn; Burn Injury

Keywords

SFDI; Spatial Frequency Domain Imaging; Burn depth; Burn injury assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth

  From enrollment to 21 days

Other Outcomes (1)

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

  From enrollment to 21 days

Interventions

Spatial Frequency Domain Imaging DIAGNOSTIC_TEST

Spatial Frequency Domain Imaging captures at specific timepoints.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Metis Foundation: lead
• The United States Institute of Surgical Research: collaborator
• Modulated Imaging Inc.: collaborator

Study Sites (1)

The United States Army Institute of Surgical Resarch

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Rodney Chan, MD

  The Metis Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Diaz, BSN

CONTACT

210-201-2206; diaz@metisfoundationusa.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (1)