NCT03144050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

May 4, 2017

Last Update Submit

May 5, 2017

Conditions

Ulcer FootDiabetes

Outcome Measures

Primary Outcomes (1)

  • Clinical risk category

    risk assessment based on clinical signs

    immediate

Secondary Outcomes (1)

  • Ulcer incidence

    1 year

Study Arms (6)

0

Control - no diabetes

Device: SFDI Imaging

1

Diabetes

Device: SFDI Imaging

2

Diabetes w/neuropathy

Device: SFDI Imaging

3

Diabetes with vascular disease

Device: SFDI Imaging

4

Diabetes w/healed ulcer

Device: SFDI Imaging

5

Diabetes with current ulcer

Device: SFDI Imaging

Interventions

SFDI ImagingDEVICE

Imaging with SFDI device

Also known as: OxImager
012345

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any person at risk for foot ulcer formation

You may not qualify if:

  • Pregnant/lactating women
  • Rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

Los Angeles, California, 90034, United States

RECRUITING

MeSH Terms

Conditions

Foot UlcerDiabetes Mellitus

Condition Hierarchy (Ancestors)

Foot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin UlcerGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Kalvin Yu, MD

CONTACT

6264053906kalvin.c.yu@kp.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

April 14, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

US(1)