Glucose Monitoring in Tissue Transfers | NCT00962130

Studies
Glucose Monitoring in Tissue Transfers

NCT00962130

Sponsor

University of Wisconsin, Madison

Status

Withdrawn

Last Update Posted

Mar 20, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Reconstructive Tissue Surgery

Interventions

Continuous glucose monitoring system

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled.

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Aug 17, 2009

First Submission Date that Met QC Criteria

Aug 18, 2009

First Posted Date

Aug 19, 2009Estimated

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

Mar 16, 2018

Last Update Posted Date

Mar 20, 2018Actual

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 purpose of this study is to determine if 1) a continuous glucose monitoring system can measure glucose levels in transferred tissue during reconstructive surgery, and 2) if glucose measurements from a continuous glucose monitoring system correlate with tissue blood perfusion.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blood Glucose Measurement	Experimental	Subjects have sensors placed on skin before surgery and these sensors will measure the subject's glucose until the third day after surgery when they are removed.	Device: Continuous glucose monitoring system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous glucose monitoring system	Device	one or two monitors will be placed in the tissue to be transferred	Blood Glucose Measurement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perfusion and tissue transfer outcome during reconstructive surgery predicted by continuous glucose monitoring of tissue		Up to three days post-op

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

presence of a soft tissue deformity where reconstruction with a pedicled or free tissue transfer is indicated
age 18 and over
ability to follow-up post-operatively

Exclusion Criteria:

age less than 18
prisoner status
inability to participate in a standard post-operative follow-up visit

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy King, MD, PhD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53792	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000095583	Continuous Glucose Monitoring

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided