Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-04 @ 10:19 AM
Study NCT ID:
NCT05347420
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2022-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The quantitative Neuropad test', 'timeFrame': '1 day', 'description': 'The diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy'}], 'secondaryOutcomes': [{'measure': 'The visual Neuropad test', 'timeFrame': '1 day', 'description': 'The diagnostic vaule of visual Neuropad for diabetic peripheral neuropathy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy', 'detailedDescription': 'This is a diagnostic study. Every patient will undertake Neuropad test, inculding the visual and quantitative screening tests. The visual screening test includes whether the Neuropad test paper changes completely from blue to pink within 10 minutes (visual screening test a) and the time to complete color change (visual screening test b). the quantitative screening test using a handheld color scanner to scan the rate of color change, which estimated by the slope of the Neuropad color change per minute. The visual and quantitative screening tests were compared when the Neuropathy Disability Score (NDS) and the Neurological Symptom Score (NSS) combined score as diagnostic criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 diabetes in the inpatient ward of the Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) diagnosed type 2 diabetic patients; 2) age between 18 and 80 years.\n\nExclusion Criteria:\n\n1\\) patients with type 1 diabetes, secondary diabetes, and patients with pre-existing diabetic foot; 2) exclusion of the following clinical conditions: foot skin lesions (scarring, rash, flaking skin, infection, etc. on the skin of the test site), peripheral arterial occlusive disease, long-term heavy smoking, chronic alcohol abuse, thyroid disease, liver insufficiency (more than 3-fold increase in liver enzymes), renal insufficiency (eGFR ≤ 30 mL /min/1.73m2), acute and chronic infections, cervical and lumbar spine diseases, bone and joint system diseases, other neurological diseases, autoimmune diseases, malignant tumors, psychiatric or psychological diseases, taking drugs that affect autonomic function, and combined with other diseases that can cause peripheral neuropathy; 3) those who cannot complete the experiment as required.'}, 'identificationModule': {'nctId': 'NCT05347420', 'briefTitle': 'Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy', 'orgStudyIdInfo': {'id': '2020-403'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic peripheral neuropathy', 'description': 'Patients with diabetic peripheral neuropathy', 'interventionNames': ['Diagnostic Test: The visual Neuropad test and the quantitative Neuropad test']}, {'label': 'non diabetic peripheral neuropathy', 'description': 'Patient without diabetic peripheral neuropathy', 'interventionNames': ['Diagnostic Test: The visual Neuropad test and the quantitative Neuropad test']}], 'interventions': [{'name': 'The visual Neuropad test and the quantitative Neuropad test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The visual screening test includes whether the Neuropad test paper changes completely from blue to pink within 10 minutes (visual screening test a) and the time to complete color change (visual screening test b). the quantitative screening test using a handheld color scanner to scan the rate of color change, which estimated by the slope of the Neuropad color change per minute.', 'armGroupLabels': ['Diabetic peripheral neuropathy', 'non diabetic peripheral neuropathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rong Li, PHD', 'role': 'CONTACT', 'email': 'rongli@hospital.cqmu.edu.cn', 'phone': '+86 23 89011552'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Rong Li, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rong Li', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}