Comparing the Ultrasound Appearance of the Sciatic Nerve With Its Appearance Under a Microscope

Withdrawn

• Conditions: Diabetes

• Registration Number: NCT02384447
• Lead Sponsor: University of Toledo Health Science Campus

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-08
• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2015-03-04
• Last Update Submitted: 2015-03-04
• Study First Posted: 2015-03-10
• Last Update Posted: 2015-03-10
• Primary Completion: 2015-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diabetes
• Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes

Exclusion Criteria

• Minors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ultrasonographic appearance	at examination before surgery	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.

Trial Locations

Locations (1)

University of Toledo, Health Science Campus; 🇺🇸 Toledo, Ohio, United States