Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT05178459
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2021-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2021-12-15', 'studyFirstSubmitQcDate': '2021-12-15', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sudomotor dysfunction diagnostic performance evaluation', 'timeFrame': '10 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet.', 'timeFrame': '10 months', 'description': '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.'}, {'measure': 'Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires', 'timeFrame': '10 months', 'description': 'The correlation between diabetes neuropathy questionnair es and Withings WBS08.'}, {'measure': 'Safety use of this device', 'timeFrame': '10 months', 'description': 'The rate of adverse effects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuropathy']}, 'referencesModule': {'references': [{'pmid': '38020587', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.', 'detailedDescription': 'Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In and out patients from endocrinology and neuropathy departments', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is an adult, man or woman (18 years old or more)\n* Subjects affiliated or eligible to a social security system\n* Subjects having expressed their consent to take part in the study\n* Two type of patients are included in the study :\n\n * Patients having diabetes (80% of the inclusion)\n * Non diabetic patients having a lower limbs neuropathy (20% of the inclusion)\n\nExclusion Criteria:\n\n* Minors under 18 years old\n* Subject is pregnant or trying to get pregnant\n* Subjects having a pacemaker\n* Subjects having refused to give their consent\n* Vulnerable subjects according to the French regulation in force:\n\n * Individuals deprived of liberty by a court, medical or administrative order\n * Individuals legally protected or unable to express their consent to take part in the study\n * Individuals unaffiliated to or not beneficiary of a social security system\n * Individuals who fit in multiple categories above\n* Individuals linguistically or mentally unable to express their consent\n* Individuals having an lower limb amputation bigger than toes\n* Individuals not able to stand still for a few minutes\n* Individuals under antidepressant medications'}, 'identificationModule': {'nctId': 'NCT05178459', 'acronym': 'WISUDO', 'briefTitle': 'Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale', 'organization': {'class': 'INDUSTRY', 'fullName': 'Withings'}, 'officialTitle': 'Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale', 'orgStudyIdInfo': {'id': '2021-A02624-37'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic', 'description': 'Patient diagnosed with diabetes', 'interventionNames': ['Diagnostic Test: Neuropathy measurement']}, {'label': 'Neuropathic without diabetes', 'description': 'Patient diagnosed with neuropathy without diabetes', 'interventionNames': ['Diagnostic Test: Neuropathy measurement']}], 'interventions': [{'name': 'Neuropathy measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.', 'armGroupLabels': ['Diabetic', 'Neuropathic without diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Henri-Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Lariboisière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Bichat-Claude Bernard Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Louis Potier, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bichat-Claude Bernard Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Withings', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}