Optical Imaging For Assessment of Foot Perfusion
- Conditions
- Ulcer FootDiabetes
- Interventions
- Device: SFDI Imaging
- Registration Number
- NCT03144050
- Lead Sponsor
- Modulated Imaging Inc.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- Pregnant/lactating women
- Rheumatoid arthritis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 SFDI Imaging Diabetes 3 SFDI Imaging Diabetes with vascular disease 4 SFDI Imaging Diabetes w/healed ulcer 2 SFDI Imaging Diabetes w/neuropathy 5 SFDI Imaging Diabetes with current ulcer 0 SFDI Imaging Control - no diabetes
- Primary Outcome Measures
Name Time Method Clinical risk category immediate risk assessment based on clinical signs
- Secondary Outcome Measures
Name Time Method Ulcer incidence 1 year Ulcer formation
Trial Locations
- Locations (1)
Kaiser Permanente
🇺🇸Los Angeles, California, United States