We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glucose Monitoring in Tissue Transfers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962130
First Posted: August 19, 2009
Last Update Posted: December 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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.

Condition Intervention
Reconstructive Tissue Surgery Device: Continuous glucose monitoring system

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Glucose Monitoring in Tissue Transfers

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Perfusion and tissue transfer outcome during reconstructive surgery predicted by continuous glucose monitoring of tissue [ Time Frame: Up to three days post-op ]

Enrollment: 3
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blood Glucose Measurement
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
one or two monitors will be placed in the tissue to be transferred

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962130


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Timothy King, MD, PhD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00962130     History of Changes
Other Study ID Numbers: H-2008-0066
First Submitted: August 17, 2009
First Posted: August 19, 2009
Last Update Posted: December 30, 2016
Last Verified: December 2016

Keywords provided by University of Wisconsin, Madison:
tissue perfusion
reconstructive surgery
continuous glucose monitoring


To Top