BurnNCT06921421
Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging
An observational study of Burn and Burn Injury, run by The Metis Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn, Burn Injury
- What is being tested?
- Spatial Frequency Domain Imaging
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to Oct 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients 18 years of age or older
- Thermal burns of any depth (superficial, deep partial thickness, or full thickness).
Who cannot join
- Patients less than 18 years of age
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
The United States Army Institute of Surgical Resarch
Fort Sam Houston, Texas, 78234
About this study
Official title: 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).
- Conditions
- Burn, Burn Injury
- Being tested
- Spatial Frequency Domain Imaging
- Keywords
- SFDI, Spatial Frequency Domain Imaging, Burn depth, Burn injury assessment
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial Frequency Domain ImagingDiagnostic test
Spatial Frequency Domain Imaging captures at specific timepoints.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 21 days
Secondary 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).
Measured: From enrollment to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start3 Jun 2025
- Primary completion10 Apr 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Army Institute of Surgical Research, Modulated Imaging Inc.
- Responsible party
- Sponsor
- Investigators
- Rodney Chan, MD, Principal investigator, The Metis Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921421
- Sponsor's protocol ID
- H-25-017
- Other IDs
- MTEC-22-08-BDA-007
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided