Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-27 @ 9:40 AM
Study NCT ID:
NCT03144050
Status:
UNKNOWN
Last Update Posted:
2017-05-08
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Imaging For Assessment of Foot Perfusion
Sponsor:
Modulated Imaging Inc.
Organization:
Study Overview
Official Title:
Optical Imaging For Assessment of Foot Perfusion
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: