Comparing the Ultrasound Appearance of the Sciatic Nerve With Its Appearance Under a Microscope
Correlation of the Ultrasound Appearance of the Sciatic Nerve With Its Histologic Appearance in Pathology Specimens Obtained From Patients Undergoing Above Knee Amputation
1 other identifier
observational
N/A
1 country
1
Brief Summary
The investigators are proposing to conduct this study to compare the ultrasonographic appearance of the sciatic nerve with their corresponding histologic architecture. Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled. We intend to do an ultrasound examination of the sciatic nerve at its bifurcation (about 4 inches above the knee). The investigators would mark the area on the skin where the image is obtained. Following surgery we will conduct a histologic examination of the nerve at the same site. Ultrasound examination is not standard of care, but is a fairly noninvasive procedure and does not add any risk to the subject. Histologic examination of the nerve is also not standard of care, but is conducted on a pathology specimen
Trial Health
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Started Jun 2014
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 7, 2014
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 10, 2015
August 1, 2014
1 year
August 7, 2014
March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ultrasonographic appearance
There is outcome measure pe se. This is an observational study. We intend to study the ultrasonographic appearance of the sciatic nerve and compare this ultrasonographic appearance with the histologic appearance of the nerve. We know the nerve in diabetic neuropathy appears ultrasonographically different than a normal nerve. We just want to study the changed appearance of the nerve under ultrasound examination with the corresponding appearance of the nerve under the microscope.
at examination before surgery
Study Arms (1)
Knee Amputation
Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled
Eligibility Criteria
Subjects suffering from long standing diabetes and scheduled to undergo an above knee amputation
You may qualify if:
- Diabetes
- Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes
You may not qualify if:
- Minors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Toledo, Health Science Campus
Toledo, Ohio, 43614, United States
Biospecimen
Amputated extremity for histologic examination of the sciatic nerve.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shashi B Bhatt, MD
University of Toledo
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 7, 2014
First Posted
March 10, 2015
Study Start
June 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2016
Last Updated
March 10, 2015
Record last verified: 2014-08