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Completed

NCT Number: NCT05178459

Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale

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

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Key information

Conditions

Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henri-Mondor Hospital, Créteil, Île-de-France Region, France

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About this study

Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 :
  • Patients having diabetes (80% of the inclusion)
  • Non diabetic patients having a lower limbs neuropathy (20% of the inclusion)

Exclusion criteria

  • 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

Treatment and study plan

Neuropathy measurement

Diagnostic Test

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

Primary outcomes

  1. Sudomotor dysfunction diagnostic performance evaluation

    Time frame: 10 months

    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).

Secondary outcomes

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

    Time frame: 10 months

    The root-mean-square error (RMSE) and the mean absolute error (MAE) between the sudomotor function value measured by the Withings WBS08 and the Sudoscan as reference on each foot and by averagin g both feet.

  2. Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires

    Time frame: 10 months

    The correlation between diabetes neuropathy questionnair es and Withings WBS08.

  3. Safety use of this device

    Time frame: 10 months

    The rate of adverse effects.

Sponsors and collaborators

Lead sponsor

Withings

Industry

Registry information

Acronym: WISUDO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2022
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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