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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03144050
Other study ID # 11150
Secondary ID
Status Recruiting
Phase N/A
First received May 4, 2017
Last updated May 5, 2017
Start date April 14, 2017
Est. completion date July 31, 2018

Study information

Verified date May 2017
Source Modulated Imaging Inc.
Contact Kalvin Yu, MD
Phone 6264053906
Email kalvin.c.yu@kp.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Exclusion Criteria:

- Pregnant/lactating women

- Rheumatoid arthritis

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SFDI Imaging
Imaging with SFDI device

Locations

Country Name City State
United States Kaiser Permanente Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Modulated Imaging Inc. Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical risk category risk assessment based on clinical signs immediate
Secondary Ulcer incidence Ulcer formation 1 year
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