Optical Imaging For Assessment of Foot Perfusion | NCT03144050

Studies
Optical Imaging For Assessment of Foot Perfusion

NCT03144050

Sponsor

Modulated Imaging Inc.

Status

Unknown status

Last Update Posted

May 8, 2017Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Ulcer Foot
Diabetes

Interventions

SFDI Imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2017Actual

Primary Completion Date

Jul 31, 2018Estimated

Completion Date

Jul 31, 2018Estimated

First Submitted Date

May 4, 2017

First Submission Date that Met QC Criteria

May 5, 2017

First Posted Date

May 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2017

Last Update Posted Date

May 8, 2017Actual

Name	Class
Kaiser Permanente	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SFDI Imaging	Device	Imaging with SFDI device	0 1 2 3 4 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical risk category	risk assessment based on clinical signs	immediate

Secondary Outcomes

Measure	Description	Time Frame
Ulcer incidence	Ulcer formation	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

Pregnant/lactating women
Rheumatoid arthritis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any person at risk for foot ulcer formation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kalvin Yu, MD	Contact	6264053906		kalvin.c.yu@kp.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente	Recruiting	Los Angeles	California	90034	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016523	Foot Ulcer
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D005534	Foot Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D007871	Leg Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided