Optical Imaging For Assessment of Foot Perfusion

May 5, 2017 updated by: Modulated Imaging Inc.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90034
        • Recruiting
        • Kaiser Permanente
        • Contact:
          • Kalvin Yu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any person at risk for foot ulcer formation

Description

Inclusion Criteria:

-

Exclusion Criteria:

  • Pregnant/lactating women
  • Rheumatoid arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Device: SFDI Imaging
Imaging with SFDI device
Other Names:
  • OxImager
1
Diabetes
Device: SFDI Imaging
Imaging with SFDI device
Other Names:
  • OxImager
2
Diabetes w/neuropathy
Device: SFDI Imaging
Imaging with SFDI device
Other Names:
  • OxImager
3
Diabetes with vascular disease
Device: SFDI Imaging
Imaging with SFDI device
Other Names:
  • OxImager
4
Diabetes w/healed ulcer
Device: SFDI Imaging
Imaging with SFDI device
Other Names:
  • OxImager
5
Diabetes with current ulcer
Device: SFDI Imaging
Imaging with SFDI device
Other Names:
  • OxImager

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical risk category
Time Frame: immediate
risk assessment based on clinical signs
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ulcer incidence
Time Frame: 1 year
Ulcer formation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Modulated Imaging Inc.

Collaborators

Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 14, 2017

Primary Completion (ANTICIPATED)

July 31, 2018

Study Completion (ANTICIPATED)

July 31, 2018

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (ACTUAL)

May 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11150 (Registry Identifier: DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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