Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Metis Foundation
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years of age or older
Thermal burns of any depth (superficial, deep partial thickness, or full thickness).
Disqualifiers
Patients less than 18 years of age
Pregnant or breastfeeding women
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Spatial Frequency Domain Imaging
Diagnostic testSpatial Frequency Domain Imaging captures at specific timepoints.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
From enrollment to 21 daysSecondary outcomes
1
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).
Time frame
From enrollment to 21 daysOther outcomes
1
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).
Time frame
From enrollment to 21 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Metis Foundation
Lead sponsor
The United States Institute of Surgical Research
Collaborator
Modulated Imaging Inc.
Collaborator
Source ClinicalTrials.gov
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