Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner and QST

Erythermalgia Clinical Trial

Official title:

Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044340
• Other study ID #: ERYTHROMELALGY
• Status: Completed
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: April 17, 2019

Study information

• Verified date: April 2019
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Erythromelalgy (EM) is a vascular syndrome very rare affecting the feet. This disease evolve by crisis when the feet extremities become red hot and painful. There are several types of EM but this study concern the adult primitive form. For a long time, the physiopathology was not described but now we know that there is a vascular form, with microcirculatory dysfunction and a neurologic form with small fibers neuropathy. The diagnostic of neurologic form is based on clinical evaluation (DN4 questionnaire, UENS scale...) and an electromyography. Thermotest, a medical device which measure the thermic sensitivity is used to quantify neuropathy. More recently Sudoscan, a device measuring cutaneous impedance to chloride ions detect small nervous fiber in diabetic patients with good correlation with Thermotest.

The purpose of this study is to analyze the vascular side and the neurologic side on patients consulting for Erythromelalgy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 17, 2019
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pain with burn feeling at hands and feet extremities

• Crisis activated by the heat

• Age > 18 years old

Exclusion Criteria:

• Patients who had burn in extremities

Related Conditions & MeSH terms

• Erythermalgia
• Erythromelalgia

Intervention

Other:
• impedance measurement and pain evaluation
Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Chlorine ion production change	patient will be measured the impedance of chlorinates ions by Sudoscan	Day1
Primary	Assessment of Temperature changing sensitivity	Patients will be measured their sensitivity to temperature changing using the Thermotest	Day1