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

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

Completed

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

History of heart failure
Rheumatoid arthritis
Pregnant or lactating women

Treatment and study plan

Spatial Frequency Domain Imaging (SFDI)

Device

Observational study to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers using Reflect RS

Other names: Reflect RS

Primary outcomes

Perfusion in lower extremities

Time frame: 12-month

SFDI data outputs

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

Modulated Imaging Inc.

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Nov 14, 2017
Registry last updated: Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed