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

Sponsor

Groupe Hospitalier Paris Saint Joseph (Other)

Overall Status

Completed

CT.gov ID

NCT03044340

Collaborator

(none)

Enrollment

Location

Arm

27.1

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erythermalgia	Other: impedance measurement and pain evaluation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner

Actual Study Start Date :

Jan 12, 2017

Actual Primary Completion Date :

Jan 18, 2018

Actual Study Completion Date :

Apr 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: erythermalgia patient patient will be measured chlorine ions impedance with the SUDOSCAN and evaluation on pain du to temperature with the THERMOTEST	Other: impedance measurement and pain evaluation Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST

Arm

Intervention/Treatment

Experimental: erythermalgia patient

patient will be measured chlorine ions impedance with the SUDOSCAN and evaluation on pain du to temperature with the THERMOTEST

Other: impedance measurement and pain evaluation

Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST

Outcome Measures

Primary Outcome Measures

Assessment of Chlorine ion production change [Day1]
patient will be measured the impedance of chlorinates ions by Sudoscan
Assessment of Temperature changing sensitivity [Day1]
Patients will be measured their sensitivity to temperature changing using the Thermotest

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France	France	75014

Sponsors and Collaborators

Groupe Hospitalier Paris Saint Joseph

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Groupe Hospitalier Paris Saint Joseph

ClinicalTrials.gov Identifier:

NCT03044340

Other Study ID Numbers:

ERYTHROMELALGY

First Posted:

Feb 7, 2017

Last Update Posted:

Apr 25, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Erythromelalgia

Study Results

No Results Posted as of Apr 25, 2019