Clincosm LogoSign in Get a demo

Optical Imaging For Assessment of Foot Perfusion

Sponsor
Modulated Imaging Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03144050
Collaborator
Kaiser Permanente (Other)
400
Enrollment
1
Location
15.5
Anticipated Duration (Months)
25.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SFDI Imaging

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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Optical Imaging For Assessment of Foot Perfusion
Actual Study Start Date :
Apr 14, 2017
Anticipated Primary Completion Date :
Jul 31, 2018
Anticipated Study Completion Date :
Jul 31, 2018

Arms and Interventions

Arm Intervention/Treatment
0

Control - no diabetes

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical risk category [immediate]

      risk assessment based on clinical signs

    Secondary Outcome Measures

    1. Ulcer incidence [1 year]

      Ulcer formation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Exclusion Criteria:

    • Pregnant/lactating women

    • Rheumatoid arthritis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Los Angeles California United States 90034

    Sponsors and Collaborators

    • Modulated Imaging Inc.
    • Kaiser Permanente

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Modulated Imaging Inc.
    ClinicalTrials.gov Identifier:
    NCT03144050
    Other Study ID Numbers:
    • 11150
    First Posted:
    May 8, 2017
    Last Update Posted:
    May 8, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Foot Ulcer

    Study Results

    No Results Posted as of May 8, 2017