Diabetes, Ulcer Foot
Conditions
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
Interventions
DEVICESFDI Imaging
Imaging with SFDI device
Sponsors
Kaiser Permanente
Modulated Imaging Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\-
Exclusion criteria
* Pregnant/lactating women * Rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical risk category | immediate | risk assessment based on clinical signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer incidence | 1 year | Ulcer formation |
Countries
United States
Contacts
Primary ContactKalvin Yu, MD
Outcome results
None listed