- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01498211
Normative Data of Intra-epidermal Nerve Fiber Density
April 12, 2019 updated by: University Hospital, Strasbourg, France
Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin
Intra-epidermal nerve fiber density can be assessed using skin biopsy.
A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population.
To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.
Study Overview
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Besançon, France, 25030
- CHU de Besancon
-
Nancy, France, 54035
- CHU de Nancy
-
Strasbourg, France, 67091
- Hôpitaux Universitaires de Strasbourg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Man or woman between 20-80 years old
- Normal subjects without pain and neurological impairment
- No history of neurological disorder
- Normal neurological examination
- Normal ECG
- Normal clotting sample from less than 6 months
- Available by phone
Exclusion criteria :
- History of alcoholic intoxication or chemotherapy
- History of diabetes, kidney insufficiency, monoclonal gammapathy, B/C hepatitis, HIV, coeliac disease, sicca syndrome, raynaud syndrome, systemic erythematous lupus, Fabry disease, amylosis, vascularitis
- Contraindication to xylocaïn with adrenalin
- At the site of biopsy : surgery, skin pathology, infection, vascular insufficiency
- Innate or acquired immunosuppression
- Innate or acquired clotting abnormality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Biopsy
|
3 mm punch biopsy of the skin at the distal leg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure density of intraepidermic nervous fibres by optical and electronic microscopy in a population of healthy witnesses according to the age and the sex.
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
May 1, 2014
Study Registration Dates
First Submitted
December 12, 2011
First Submitted That Met QC Criteria
December 20, 2011
First Posted (ESTIMATE)
December 23, 2011
Study Record Updates
Last Update Posted (ACTUAL)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4961
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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