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
Qualifiers
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 design
Treatments tested in this trial
- Spatial Frequency Domain Imaging
Treatment groups
Sponsors and collaborators
The Metis Foundation
Lead sponsor
The United States Institute of Surgical Research
Collaborator
Modulated Imaging Inc.
Collaborator