Reference values for peptidergic and non-peptidergic intra-epidermal nerve fiber density in the human hand and distal leg.
Withdrawn
- Conditions
- not applicable: healthy volunteers10034606
- Registration Number
- NL-OMON46631
- Lead Sponsor
- RadboudUMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
- competent male or female volunteers of 18 years or older, who can speak and understand the Dutch language
Exclusion Criteria
- Proven or suspected neuropathy
- Nerve injury and/or neuropathy in one or both hands or legs
- Abnormal neurological exam
- Diabetes mellitus
- Vitamin B12 deficiency
- Hypothyroidism
- Malignancy
- Renal failure
- HIV/AIDS
- skin disorders at the hands or legs
- (history of) chemotherapy
- (history of) chronic alcohol abusis, >4IU/day
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome will be the peptidergic and non-peptidergic intra-epidermal<br /><br>nerve fiber density of the hand and distal leg. Reference values for<br /><br>intra-epidermal nerve fiber density will be stratified for age and for gender<br /><br>and will be provided as the 5th percentile and the mean. Intra-epidermal nerve<br /><br>fiber density will be expressed in fibers/mm. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome is the difference in intra-epidermal nerve fiber density<br /><br>between the 3 different biopsy sites of the hand. Furthermore, we will describe<br /><br>adverse events in case they occur.</p><br>