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

Diabetes Clinical Trial

Official title:

Correlation of the Ultrasound Appearance of the Sciatic Nerve With Its Histologic Appearance in Pathology Specimens Obtained From Patients Undergoing Above Knee Amputation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02384447
• Other study ID #: UTIRB 0000200125
• Status: Withdrawn
• Phase: N/A
• First received: August 7, 2014
• Last updated: March 4, 2015
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2014
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diabetes

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

Exclusion Criteria:

• Minors

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No