NCT05178459

Brief Summary

The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

December 15, 2021

Last Update Submit

January 23, 2023

Conditions

Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Sudomotor dysfunction diagnostic performance evaluation

    The diagnostic performance of the Withings WBS08 will be established using the sensitivity and the specificity for an electrochemical skin conductance threshold (moderate dysfunction and severe dysfunction).

    10 months

Secondary Outcomes (3)

  • Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet.

    10 months

  • Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires

    10 months

  • Safety use of this device

    10 months

Study Arms (2)

Diabetic

Patient diagnosed with diabetes

Diagnostic Test: Neuropathy measurement

Neuropathic without diabetes

Patient diagnosed with neuropathy without diabetes

Diagnostic Test: Neuropathy measurement

Interventions

Neuropathy measurementDIAGNOSTIC_TEST

Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.

DiabeticNeuropathic without diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In and out patients from endocrinology and neuropathy departments

You may qualify if:

  • The subject is an adult, man or woman (18 years old or more)
  • Subjects affiliated or eligible to a social security system
  • Subjects having expressed their consent to take part in the study
  • Two type of patients are included in the study :

You may not qualify if:

  • Minors under 18 years old
  • Subject is pregnant or trying to get pregnant
  • Subjects having a pacemaker
  • Subjects having refused to give their consent
  • Vulnerable subjects according to the French regulation in force:
  • Individuals deprived of liberty by a court, medical or administrative order
  • Individuals legally protected or unable to express their consent to take part in the study
  • Individuals unaffiliated to or not beneficiary of a social security system
  • Individuals who fit in multiple categories above
  • Individuals linguistically or mentally unable to express their consent
  • Individuals having an lower limb amputation bigger than toes
  • Individuals not able to stand still for a few minutes
  • Individuals under antidepressant medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Henri-Mondor Hospital

Créteil, Île-de-France Region, 94000, France

Location

Lariboisière Hospital

Paris, Île-de-France Region, 75010, France

Location

Cochin Hospital

Paris, Île-de-France Region, 75014, France

Location

Bichat-Claude Bernard Hospital

Paris, Île-de-France Region, 75018, France

Location

Related Publications (1)

  • Riveline JP, Mallone R, Tiercelin C, Yaker F, Alexandre-Heymann L, Khelifaoui L, Travert F, Fertichon C, Julla JB, Vidal-Trecan T, Potier L, Gautier JF, Larger E, Lefaucheur JP. Validation of the Body Scan(R), a new device to detect small fiber neuropathy by assessment of the sudomotor function: agreement with the Sudoscan(R). Front Neurol. 2023 Oct 31;14:1256984. doi: 10.3389/fneur.2023.1256984. eCollection 2023.

    PMID: 38020587DERIVED

Study Officials

  • Louis Potier, Dr

    Bichat-Claude Bernard Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

January 5, 2022

Study Start

March 11, 2022

Primary Completion

July 22, 2022

Study Completion

August 8, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)