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NCT03341559 Clinical Trial

Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing

Diabetic Foot Ulcer Clinical Trial

Official title:
Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03341559
Other study ID # APP-17-06886
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2018
Est. completion date February 13, 2020

Study information
Verified date March 2020
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date February 13, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

1. Subjects with an existing diabetic foot ulcer

2. Subjects determined "at risk" for an ulcer

Exclusion Criteria:

1. History of heart failure

2. Rheumatoid arthritis

3. Pregnant or lactating women

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Spatial Frequency Domain Imaging (SFDI)
Observational study to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers using Reflect RS

Locations
Country Name City State
United States Keck Medical Center of USC Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
University of Southern California Modulated Imaging Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perfusion in lower extremities SFDI data outputs 12-month
See also
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