Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

The Metis Foundation

Status: Not yet enrolling

Conditions: Burn Injury; Burn

Treatments: Diagnostic Test: Spatial Frequency Domain Imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06921421

MTEC-22-08-BDA-007 (Other Grant/Funding Number)

H-25-017

Details and patient eligibility

About

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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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