DiabetesNCT02384447
Comparing the Ultrasound Appearance of the Sciatic Nerve With Its Appearance Under a Microscope
An observational study of Diabetes, run by University of Toledo Health Science Campus at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects suffering from long standing diabetes and scheduled to undergo an above knee amputation
Who may be able to join
- Diabetes
- Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes
Who cannot join
- Minors
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43614
About this study
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
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
- Conditions
- Diabetes
- Keywords
- above knee amputation, sciatic nerve, ultrasonography, histology
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee Amputation | Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at examination before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shashi Bhatt, MD, University of Toledo Health Science Campus
- Investigators
- Shashi B Bhatt, MD, Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384447
- Sponsor's protocol ID
- UTIRB 0000200125
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02384447
- Acronym / sponsor ID
- UTIRB 0000200125
- Conditions
- Diabetes
- Keywords
- above knee amputation, sciatic nerve, ultrasonography, histology
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Amputation | – | –Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from long standing diabetes and scheduled to undergo an above knee amputation
Key inclusion criteria (2 listed)
- Diabetes
- Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes
Key exclusion criteria (1 listed)
- Minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ultrasonographic appearance
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shashi B Bhatt, MD principal investigator
University of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by University of Toledo Health Science Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasonographic appearance (time frame: at examination before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.