Small fibre neuropathy in Fabry*s disease

Small fibre neuropathy in Fabry*s disease - Small fibre neuropathy in Fabry*s disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31065

Enrollment

Registered

2007-02-27

Start date

2007-03-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

painful neuropathy small diameter nerve fibre neuropathy

Interventions

None listed

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age 12 years or older 2. A diagnosis of Fabry disease as proven by enzyme activity (males) or DNA mutation analysis (females)

Exclusion criteria

Exclusion criteria: 1. Pre-existent venous insufficiency, confirmed by echo Doppler or a history of ulcus cruris

Design outcomes

Primary

Measure	Time frame
The QST protocol will be expressed as Z-score QST profiles. Skin biopsies will be expressed as intra-epidermal nerve fibre densities (IENFD). An IENFD of less than the 5th percentile of healthy humans is considered to be abnormal. Autonomic function will be expressed as changes in heart rate and blood pressure in response to standing up, forced breathing and the Valsalva*s manoeuvre. The results will be compared to well-established normative values per age-group.	—

Measure

Time frame

The QST protocol will be expressed as Z-score QST profiles. Skin biopsies will be expressed as intra-epidermal nerve fibre densities (IENFD). An IENFD of less than the 5th percentile of healthy humans is considered to be abnormal. Autonomic function will be expressed as changes in heart rate and blood pressure in response to standing up, forced breathing and the Valsalva*s manoeuvre. The results will be compared to well-established normative values per age-group.

—

Secondary

Measure	Time frame
None	—

Countries

Netherlands

Outcome results