- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02384447
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
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
Studieoversigt
Status
Betingelser
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Ohio
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Toledo, Ohio, Forenede Stater, 43614
- University of Toledo, Health Science Campus
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Diabetes
- Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes
Exclusion Criteria:
- Minors
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Knee Amputation
Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
ultrasonographic appearance
Tidsramme: 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.
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at examination before surgery
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Shashi B Bhatt, MD, University of Toledo
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UTIRB 0000200125
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