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

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT03341559
Collaborator
Modulated Imaging Inc. (Industry)
23
Enrollment
1
Location
22.8
Actual Duration (Months)
1
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 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

Condition or Disease Intervention/Treatment Phase
  • Device: Spatial Frequency Domain Imaging (SFDI)

Study Design

Study Type:
Observational
Actual Enrollment :
23 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Spatial Frequency Domain Imaging (SFD) for Assessment of Diabetic Foot Ulcer Development and Healing
Actual Study Start Date :
Mar 20, 2018
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Feb 13, 2020

Arms and Interventions

Arm Intervention/Treatment
With Existing Diabetic Ulcers

Current DFU

Device: 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
Other Names:
  • Reflect RS

    		•
    Diabetic Ulcers in remission

    DFU in remission

    Device: 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
    Other Names:
  • Reflect RS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Perfusion in lower extremities [12-month]

      SFDI data outputs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Keck Medical Center of USC Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • Modulated Imaging Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Armstrong, Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA), University of Southern California
    ClinicalTrials.gov Identifier:
    NCT03341559
    Other Study ID Numbers:
    • APP-17-06886
    First Posted:
    Nov 14, 2017
    Last Update Posted:
    Mar 24, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Diabetic Foot
    Foot Ulcer
    Ulcer

    Study Results

    No Results Posted as of Mar 24, 2020