Optical Imaging For Assessment of Foot Perfusion

Modulated Imaging

Status: Unknown

Conditions: Diabetes; Ulcer Foot

Treatments: Device: SFDI Imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03144050

11150 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

• Pregnant/lactating women
• Rheumatoid arthritis

Trial design

400 participants in 6 patient groups

0

Description:

Control - no diabetes

Treatment:

Device: SFDI Imaging

1

Description:

Diabetes

Treatment:

Device: SFDI Imaging

2

Description:

Diabetes w/neuropathy

Treatment:

Device: SFDI Imaging

3

Description:

Diabetes with vascular disease

Treatment:

Device: SFDI Imaging

4

Description:

Diabetes w/healed ulcer

Treatment:

Device: SFDI Imaging

5

Description:

Diabetes with current ulcer

Treatment:

Device: SFDI Imaging