Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

April 8, 2025 updated by: Rodney Chan, The Metis Foundation

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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.
From enrollment to 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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).
From enrollment to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe