Optical Imaging For Assessment of Foot Perfusion

NCT ID: NCT03144050

Last Updated: 2017-05-08

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

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-14

Study Completion Date

2018-07-31

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 and to understand how it might be used in a podiatry clinic.

Detailed Description

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This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. SFDI is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. Our hypothesis is that SFDI parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. This phase of the study is designed to correlate SFDI outputs to current clinical risk categories

Conditions

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Ulcer Foot Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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0

Control - no diabetes

SFDI Imaging

Intervention Type DEVICE

Imaging with SFDI device

1

Diabetes

SFDI Imaging

Intervention Type DEVICE

Imaging with SFDI device

2

Diabetes w/neuropathy

SFDI Imaging

Intervention Type DEVICE

Imaging with SFDI device

3

Diabetes with vascular disease

SFDI Imaging

Intervention Type DEVICE

Imaging with SFDI device

4

Diabetes w/healed ulcer

SFDI Imaging

Intervention Type DEVICE

Imaging with SFDI device

5

Diabetes with current ulcer

SFDI Imaging

Intervention Type DEVICE

Imaging with SFDI device

Interventions

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SFDI Imaging

Imaging with SFDI device

Intervention Type DEVICE

Other Intervention Names

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OxImager

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Pregnant/lactating women
* Rheumatoid arthritis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

Modulated Imaging Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaiser Permanente

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kalvin Yu, MD

Role: CONTACT

6264053906

Facility Contacts

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Kalvin Yu, MD

Role: primary

Other Identifiers

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11150

Identifier Type: -

Identifier Source: org_study_id

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