- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Contacts et emplacements
Lieux d'étude
-
-
Ohio
-
Toledo, Ohio, États-Unis, 43614
- University of Toledo, Health Science Campus
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Diabetes
- Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes
Exclusion Criteria:
- Minors
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
Knee Amputation
Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
ultrasonographic appearance
Délai: 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.
|
at examination before surgery
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Shashi B Bhatt, MD, University of Toledo
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- UTIRB 0000200125
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .