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

NCT ID: NCT02384447

Last Updated: 2015-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Knee Amputation

Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Minors
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toledo Health Science Campus

OTHER

Sponsor Role lead

Responsible Party

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Shashi Bhatt, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shashi B Bhatt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toledo

Locations

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University of Toledo, Health Science Campus

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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UTIRB 0000200125

Identifier Type: -

Identifier Source: org_study_id

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