Use of Laser Speckle to Study Post Occlusive Reactive Hyp... | NCT01169974

Studies
Use of Laser Speckle to Study Post Occlusive Reactive Hyperhemia in Healthy Subjects

NCT01169974

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Nov 1, 2017Actual

Enrollment

41Actual

Phase

Not provided

Conditions

Microcirculation

Interventions

tourniquet ischemia

Countries

France

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2011Actual

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 4, 2012Actual

First Submitted Date

Jul 23, 2010

First Submission Date that Met QC Criteria

Jul 23, 2010

First Posted Date

Jul 26, 2010Estimated

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

Oct 30, 2017

Last Update Posted Date

Nov 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement of cutaneous blood flow following various durations of tourniquet ischemia.

Detailed Description

Ischemia and post occlusive reactive hyperemia in the skin is tested in healthy normal subjects for tourniquet ischemias of 1, 2 & 3 minutes at rest.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy volunteers			Other: tourniquet ischemia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tourniquet ischemia	Other	Recording of cutaneous blood flow on the forearm at rest before and following tourniquet ischemias of 1 , 2 & 3 minutes	healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Laser speckle	Peak value of laser speckle signal	with 2 minutes of ischemia

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers
Affiliation to the French health system

Exclusion Criteria:

Any disease or chronic treatment

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

healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillaume Mahe	University Hospital in Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital		Angers			France

Intervention Browse Module

MeSH Terms

ID	Term
D017078	Laser-Doppler Flowmetry
D001785	Blood Gas Monitoring, Transcutaneous

Ancestor Terms

ID	Term
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D012212	Rheology

Browse Leaves

Not provided

Browse Branches

Not provided