Reconstructive Tissue SurgeryNCT00962130
Glucose Monitoring in Tissue Transfers
A study testing Continuous glucose monitoring system in people with Reconstructive Tissue Surgery, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reconstructive Tissue Surgery
- What is being tested?
- Continuous glucose monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age less than 18
- prisoner status
- inability to participate in a standard post-operative follow-up visit
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Reconstructive Tissue Surgery
- Being tested
- Continuous glucose monitoring system
- Keywords
- tissue perfusion, reconstructive surgery, continuous glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring systemDevice
one or two monitors will be placed in the tissue to be transferred
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous glucose monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion and tissue transfer outcome during reconstructive surgery predicted by continuous glucose monitoring of tissue
Measured: Up to three days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: No patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Tissue SurgeryStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy King, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962130
- Sponsor's protocol ID
- H-2008-0066
- Status last verified
- Mar 2018
- First submitted
- 17 Aug 2009
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Monitoring in Tissue Transfers
- ClinicalTrials.gov ID
- NCT00962130
- Acronym / sponsor ID
- H-2008-0066
- Conditions
- Reconstructive Tissue Surgery
- Keywords
- tissue perfusion, reconstructive surgery, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Glucose Measurement | Experimental | Device: Continuous glucose monitoring systemSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- age less than 18
- prisoner status
- inability to participate in a standard post-operative follow-up visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoring systemone or two monitors will be placed in the tissue to be transferred | Device | Blood Glucose Measurement |
Primary outcome
Perfusion and tissue transfer outcome during reconstructive surgery predicted by continuous glucose monitoring of tissue
Time frame: Up to three days post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy King, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring system in people with Reconstructive Tissue Surgery, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion and tissue transfer outcome during reconstructive surgery predicted by continuous glucose monitoring of tissue (time frame: Up to three days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.