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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02384447

Enrollment

Registered

2015-03-10

Start date

2014-06-30

Completion date

2016-06-30

Last updated

2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

above knee amputation, sciatic nerve, ultrasonography, histology

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Minors

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results