Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT04253860
Status:
TERMINATED
Last Update Posted:
2021-08-04
First Post:
2020-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048909', 'term': 'Diabetes Complications'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Due to pandemic od COVID-19, was difficult recruit patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain perception', 'timeFrame': 'Change from Baseline Pain perception at 90 days', 'description': 'Evaluation of neuropathic pain evaluated with VAS'}], 'secondaryOutcomes': [{'measure': 'Tumoral Necrosis Factor Alpha', 'timeFrame': 'Change from Baseline serum levels of TNF-alpha at 90 days', 'description': 'Serum levels of TNF-alpha'}, {'measure': 'Interleukin-6', 'timeFrame': 'Change from Baseline serum levels of IL-6 at 90 days', 'description': 'Serum levels of IL-6'}, {'measure': 'C Reactive Protein ultra-sensible', 'timeFrame': 'Change from Baseline serum levels of CRP-us at 90 days', 'description': 'Serum levels of CRP-us'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic neuropathy peripheral', 'diabetic complications', 'TENS', 'Neuropathic treatments'], 'conditions': ['Diabetic Neuropathy Peripheral']}, 'descriptionModule': {'briefSummary': 'Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic of type 2 diabetes \\> 10 years\n* Diagnostic of peripheral diabetic neuropathy less than 5 years\n* HbA1C \\> 6.5 and \\< 9%\n* Plasmatic glucose \\>140 mg/dL and lees than 350 mg/dL\n* Informed consent signed\n\nExclusion Criteria:\n\n* Use of implanted pacemaker or heart defibrillator\n* Implanted brain stimulator\n* History of alcohol abuse\n* Use of NSAID, stereoids\n* Subjects with wounds, ulcers in legs\n* Subjects with hepatic, renal o neurologic diseases'}, 'identificationModule': {'nctId': 'NCT04253860', 'briefTitle': 'Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario de Tonalá'}, 'officialTitle': 'Effect of Transcutaneous Electrical Nerve Stimulation on Pain percepción and Serum Inflammatory Markers in Patients With Peripheral Diabetic Neuropathy', 'orgStudyIdInfo': {'id': 'TENS-ND-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TENS', 'description': 'Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days', 'interventionNames': ['Device: Transcutaneous electrical neurostimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'A sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses', 'interventionNames': ['Device: Transcutaneous electrical neurostimulation']}], 'interventions': [{'name': 'Transcutaneous electrical neurostimulation', 'type': 'DEVICE', 'description': 'Sessions of 30 minutes of TENS will be applied three times a week during 90 days', 'armGroupLabels': ['Sham', 'TENS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45425', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'University of Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Arieh R Mercado Sesma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salud Enfermedad como proceso individual, CUTonalá, Universidad de Guadalajara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario de Tonalá', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Guadalajara', 'class': 'OTHER'}, {'name': 'Diabetes sin Complicaciones S.A de C.V, Mexico', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Arieh Roldán Mercado Sesma', 'investigatorAffiliation': 'Centro Universitario de Tonalá'}}}}