Anatomy of Normal Human NervesNCT01052805
Anatomy Study in Control Nerve From Normal Human
An observational study of Anatomy of Normal Human Nerves and Microscopic Study, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. To explore the pathology of nerve, vasculature in the normal control nerve 2. Compare the pathology of control nerve and nerve from amputated limb of diabetes Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Anatomy of Normal Human Nerves, Microscopic Study, Myelinated Nerve and Unmyelinated Nerve Study
- What is being tested?
- harvest nerve
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Dec 2013
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cadaveric donor patients receiving nerve graft operation
Who may be able to join
- Cadaveric donor
- Patients receiving nerve graft operation
Who cannot join
- Patient with neurologic disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jung-Hsien Hsieh, (02)23123456 ext. 2499, jhhsieh@ntuh.gov.tw
About this study
- To explore the pathology of nerve, vasculature in the normal control nerve
- Compare the pathology of control nerve and nerve from amputated limb of diabetes
Read the detailed description
Diabetic foot occurs in 15% of diabetic population (3) and 15% of the diabetic foot patients end up with lower limb amputation. Peripheral neuropathy (sensory, motor and autonomic), peripheral vascular disease, trauma, infection and poor wound healing all contribute to diabetic foot problem.
Peripheral neuropathy could be evaluated in a variety of ways, including vibratory thresholds, thermal thresholds, pressure perception thresholds, muscle strength. All these predict foot ulceration to some degree(1). Motor nerve conduction velocity is an independent predictor for the development of new foot ulcer in diabetic population.
For more detailed structural study of neuropathy in diabetic patient, we could use skin biopsy method. Skin biopsy with PGP9.5 immunohistochemistry has been demonstrated by ultrastructural studies to label the terminal portions of both small myelinated and unmyelinated nerve in the epidermis (5). Intra-epidermal nerve fiber (IENF) density is reduced in patient with impaired glucose tolerance and clinically overt diabetes (5). Previous IENF density study was performed in diabetic patients with sensory symptom but no foot ulcer. Now we tried to evaluate IENF density in severe diabetic foot patient who received below knee amputation. Skin biopsy will be performed at amputated leg. The skin biopsy area will be located at lateral side of distal leg, 10 cm above the lateral malleolus as previous protocol of our group (6). Underlying sural nerve and posterior tibial nerve will be also harvested for further ultra-structural study.
We had previous IRB for "Pathology of skin, nerve and vasculature in the amputated limb of diabetes". However, pathology of normal control nerve is important to compare the pathology of nerve from amputated limb of diabetes. For parotid cancer patients receiving radical parotidectomy, facial nerve is frequently sacrificed. Sural nerve is frequently harvested for reconstruction. Sural nerve is also frequently used in ther nerve construction surgery. During these operations, we could harvested 2 cm more sural nerve for normal nerve pathology study. For cadaveric donor patient, we also could harvest normal nerve for control study.
- Conditions
- Anatomy of Normal Human Nerves, Microscopic Study, Myelinated Nerve and Unmyelinated Nerve Study
- Being tested
- harvest nerve
- Keywords
- nerve, myelinated nerve, unmyelinated nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
harvest nerveProcedure or surgery
harvest nerve from cadaveric donor and patients receiving nerve graft operation
| Study group | Role | What they receive |
|---|---|---|
| harvest nerve | harvest nerve from cadaveric donor and patients receiving nerve graft operation Receives: Procedure: harvest nerve |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startAug 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomy of Normal Human NervesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Hsien Hsieh, MD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052805
- Sponsor's protocol ID
- 200912006R
- Status last verified
- Oct 2011
- First submitted
- 18 Jan 2010
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomy Study in Control Nerve From Normal Human
- ClinicalTrials.gov ID
- NCT01052805
- Acronym / sponsor ID
- 200912006R
- Conditions
- Anatomy of Normal Human Nerves, Microscopic Study, Myelinated Nerve and Unmyelinated Nerve Study
- Keywords
- nerve, myelinated nerve, unmyelinated nerve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Jan 2010 (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.
- To explore the pathology of nerve, vasculature in the normal control nerve
- Compare the pathology of control nerve and nerve from amputated limb of diabetes
Detailed description
Diabetic foot occurs in 15% of diabetic population (3) and 15% of the diabetic foot patients end up with lower limb amputation. Peripheral neuropathy (sensory, motor and autonomic), peripheral vascular disease, trauma, infection and poor wound healing all contribute to diabetic foot problem.
Peripheral neuropathy could be evaluated in a variety of ways, including vibratory thresholds, thermal thresholds, pressure perception thresholds, muscle strength. All these predict foot ulceration to some degree(1). Motor nerve conduction velocity is an independent predictor for the development of new foot ulcer in diabetic population.
For more detailed structural study of neuropathy in diabetic patient, we could use skin biopsy method. Skin biopsy with PGP9.5 immunohistochemistry has been demonstrated by ultrastructural studies to label the terminal portions of both small myelinated and unmyelinated nerve in the epidermis (5). Intra-epidermal nerve fiber (IENF) density is reduced in patient with impaired glucose tolerance and clinically overt diabetes (5). Previous IENF density study was performed in diabetic patients with sensory symptom but no foot ulcer. Now we tried to evaluate IENF density in severe diabetic foot patient who received below knee amputation. Skin biopsy will be performed at amputated leg. The skin biopsy area will be located at lateral side of distal leg, 10 cm above the lateral malleolus as previous protocol of our group (6). Underlying sural nerve and posterior tibial nerve will be also harvested for further ultra-structural study.
We had previous IRB for "Pathology of skin, nerve and vasculature in the amputated limb of diabetes". However, pathology of normal control nerve is important to compare the pathology of nerve from amputated limb of diabetes. For parotid cancer patients receiving radical parotidectomy, facial nerve is frequently sacrificed. Sural nerve is frequently harvested for reconstruction. Sural nerve is also frequently used in ther nerve construction surgery. During these operations, we could harvested 2 cm more sural nerve for normal nerve pathology study. For cadaveric donor patient, we also could harvest normal nerve for control study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| harvest nerve | – | Procedure: harvest nerveharvest nerve from cadaveric donor and patients receiving nerve graft operation |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cadaveric donor patients receiving nerve graft operation
Key inclusion criteria (2 listed)
- Cadaveric donor
- Patients receiving nerve graft operation
Key exclusion criteria (1 listed)
- Patient with neurologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| harvest nerveharvest nerve from cadaveric donor and patients receiving nerve graft operation | Procedure or surgery | harvest nerve |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2011.
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.
Jung-Hsien Hsieh, MD study director
National Taiwan University Hospital
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 Anatomy of Normal Human Nerves and Microscopic Study, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 21 Oct 2011. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Hsien Hsieh, MD (0972651800, jhhsieh@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 21 Oct 2011.