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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00962130
Other study ID # H-2008-0066
Secondary ID
Status Withdrawn
Phase N/A
First received August 17, 2009
Last updated March 16, 2018
Start date August 2009
Est. completion date June 2011

Study information

Verified date March 2018
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Continuous glucose monitoring system
one or two monitors will be placed in the tissue to be transferred

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

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