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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-20

Study Completion Date

2020-02-13

Brief Summary

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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

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Detailed Description

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Conditions

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Diabetic Foot Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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With Existing Diabetic Ulcers

Current DFU

Spatial Frequency Domain Imaging (SFDI)

Intervention Type DEVICE

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

Diabetic Ulcers in remission

DFU in remission

Spatial Frequency Domain Imaging (SFDI)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Reflect RS

Eligibility Criteria

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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