Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner and QST
Primary Purpose
Erythermalgia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
impedance measurement and pain evaluation
Sponsored by
About this trial
This is an interventional other trial for Erythermalgia
Eligibility Criteria
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
Sites / Locations
- Groupe Hospitalier Paris Saint Joseph
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
erythermalgia patient
Arm Description
patient will be measured chlorine ions impedance with the SUDOSCAN and evaluation on pain du to temperature with the THERMOTEST
Outcomes
Primary Outcome Measures
Assessment of Chlorine ion production change
patient will be measured the impedance of chlorinates ions by Sudoscan
Assessment of Temperature changing sensitivity
Patients will be measured their sensitivity to temperature changing using the Thermotest
Secondary Outcome Measures
Full Information
NCT ID
NCT03044340
First Posted
January 31, 2017
Last Updated
April 24, 2019
Sponsor
Fondation Hôpital Saint-Joseph
1. Study Identification
Unique Protocol Identification Number
NCT03044340
Brief Title
Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner and QST
Official Title
Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
January 18, 2018 (Actual)
Study Completion Date
April 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythermalgia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
erythermalgia patient
Arm Type
Experimental
Arm Description
patient will be measured chlorine ions impedance with the SUDOSCAN and evaluation on pain du to temperature with the THERMOTEST
Intervention Type
Other
Intervention Name(s)
impedance measurement and pain evaluation
Intervention Description
Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST
Primary Outcome Measure Information:
Title
Assessment of Chlorine ion production change
Description
patient will be measured the impedance of chlorinates ions by Sudoscan
Time Frame
Day1
Title
Assessment of Temperature changing sensitivity
Description
Patients will be measured their sensitivity to temperature changing using the Thermotest
Time Frame
Day1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner and QST
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