Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

ConditionsBurnBurn Injury
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

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

No treatment groups listed

Sponsors and collaborators

The Metis Foundation

Lead sponsor

The United States Institute of Surgical Research

Collaborator

Modulated Imaging Inc.

Collaborator