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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03341559

Enrollment

Registered

2017-11-14

Start date

2018-03-20

Completion date

2020-02-13

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer

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

Interventions

DEVICESpatial 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Perfusion in lower extremities	12-month	SFDI data outputs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026