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Reference values for peptidergic and non-peptidergic intra-epidermal nerve fiber density in the human hand and distal leg.

Reference values for peptidergic and non-peptidergic intra-epidermal nerve fiber density in the human hand and distal leg. - PANPIEF study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46631
Enrollment
120
Registered
2018-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

not applicable: healthy volunteers

Interventions

None listed

Sponsors

RadboudUMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - competent male or female volunteers of 18 years or older, who can speak and understand the Dutch language

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the peptidergic and non-peptidergic intra-epidermal nerve fiber density of the hand and distal leg. Reference values for intra-epidermal nerve fiber density will be stratified for age and for gender and will be provided as the 5th percentile and the mean. Intra-epidermal nerve fiber density will be expressed in fibers/mm.

Secondary

MeasureTime frame
The secondary outcome is the difference in intra-epidermal nerve fiber density between the 3 different biopsy sites of the hand. Furthermore, we will describe adverse events in case they occur.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)