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

University of Southern California

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Device: Spatial Frequency Domain Imaging (SFDI)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03341559

APP-17-06886

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 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

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

23 participants in 2 patient groups

With Existing Diabetic Ulcers

Description:

Current DFU

Treatment:

Device: Spatial Frequency Domain Imaging (SFDI)

Diabetic Ulcers in remission

Description:

DFU in remission

Treatment:

Device: Spatial Frequency Domain Imaging (SFDI)