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Optical Imaging For Assessment of Foot Perfusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03144050
Recruitment Status : Unknown
Verified May 2017 by Modulated Imaging Inc..
Recruitment status was:  Recruiting
First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Modulated Imaging Inc.

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
Ulcer Foot Diabetes 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

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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
0
Control - no diabetes
Device: SFDI Imaging
Imaging with SFDI device
Other Name: OxImager

1
Diabetes
Device: SFDI Imaging
Imaging with SFDI device
Other Name: OxImager

2
Diabetes w/neuropathy
Device: SFDI Imaging
Imaging with SFDI device
Other Name: OxImager

3
Diabetes with vascular disease
Device: SFDI Imaging
Imaging with SFDI device
Other Name: OxImager

4
Diabetes w/healed ulcer
Device: SFDI Imaging
Imaging with SFDI device
Other Name: OxImager

5
Diabetes with current ulcer
Device: SFDI Imaging
Imaging with SFDI device
Other Name: OxImager




Primary Outcome Measures :
  1. Clinical risk category [ Time Frame: immediate ]
    risk assessment based on clinical signs


Secondary Outcome Measures :
  1. Ulcer incidence [ Time Frame: 1 year ]
    Ulcer formation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any person at risk for foot ulcer formation
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • Pregnant/lactating women
  • Rheumatoid arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144050


Contacts
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Contact: Kalvin Yu, MD 6264053906 kalvin.c.yu@kp.org

Locations
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United States, California
Kaiser Permanente Recruiting
Los Angeles, California, United States, 90034
Contact: Kalvin Yu, MD         
Sponsors and Collaborators
Modulated Imaging Inc.
Kaiser Permanente
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Responsible Party: Modulated Imaging Inc.
ClinicalTrials.gov Identifier: NCT03144050    
Other Study ID Numbers: 11150
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Foot Ulcer
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer