NCT03144050

Optical Imaging For Assessment of Foot Perfusion

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Modulated Imaging Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.

Detailed description

This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. SFDI is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. Our hypothesis is that SFDI parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. This phase of the study is designed to correlate SFDI outputs to current clinical risk categories

Conditions

• Ulcer Foot
• Diabetes

Interventions

Type	Name	Description
DEVICE	SFDI Imaging	Imaging with SFDI device

Timeline

• Start date: 2017-04-14
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2017-05-08
• Last updated: 2017-05-08

Locations

1 site across 1 country: United States