Recruiting

Observational Study

Sponsor:

Modulated Imaging Inc.

Code:

NCT03144050

Conditions

Ulcer Foot

Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

SFDI Imaging

Study Details

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.

Conditions

Ulcer Foot

Diabetes

Study ID

NCT03144050

Start date

Apr 14, 2017

Status verified date

May, 2017

Completion date

Jul 31, 2018

Anticipated

Primary completion date

Jul 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

-

Exclusion Criteria:

  • Pregnant/lactating women
  • Rheumatoid arthritis

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

0

Control - no diabetes

1

Diabetes

2

Diabetes w/neuropathy

3

Diabetes with vascular disease

4

Diabetes w/healed ulcer

5

Diabetes with current ulcer

Interventions

SFDI Imaging

Imaging with SFDI device

Primary outcome measure

  • Clinical risk category [ Time Frame: immediate ]

Central Contacts and Locations

Central contacts

Kalvin Yu, MD

6264053906kalvin.c.yu@kp.org

Locations

Kaiser Permanente

Recruiting

Los Angeles, California, United States, 90034

More Information

Sponsor

Modulated Imaging Inc.

Last update posted

May 8, 2017

Last verified

May, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Modulated Imaging Inc. on 2017-05-08.