Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing
Completed
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Device: Spatial Frequency Domain Imaging (SFDI)
- Registration Number
- NCT03341559
- Lead Sponsor
- University of Southern California
- Brief Summary
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers.
The investigators will perform longitudinal imaging (for 12 months) in two cohorts of subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
I. Will be followed up in clinic on monthly basis for the next 12 months per standard of care II. Belong to one of the two target groups
- Subjects with an existing diabetic foot ulcer
- Subjects determined "at risk" for an ulcer
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Exclusion Criteria
- History of heart failure
- Rheumatoid arthritis
- Pregnant or lactating women
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description With Existing Diabetic Ulcers Spatial Frequency Domain Imaging (SFDI) Current DFU Diabetic Ulcers in remission Spatial Frequency Domain Imaging (SFDI) DFU in remission
- Primary Outcome Measures
Name Time Method Perfusion in lower extremities 12-month SFDI data outputs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States