Optical Imaging For Assessment of Foot Perfusion

Diabetes Clinical Trial

Official title:

Optical Imaging For Assessment of Foot Perfusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03144050
• Other study ID #: 11150
• 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
• 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

Related Conditions & MeSH terms

• Diabetes
• Ulcer Foot

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