Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-27 @ 4:14 AM
Study NCT ID:
NCT04593992
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2020-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HTEMS Treatment of Diabetic Polyneuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2020-10-14', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropathy symptom score', 'timeFrame': '12 weeks', 'description': 'Neuropathic symptoms measured by the neuropathic symptom score (NSS). Range 1-10 with higher scores indicationg a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'neuropathy', 'pain', 'HTEMS'], 'conditions': ['Diabetic Polyneuropathy']}, 'descriptionModule': {'briefSummary': 'So far, there are no sufficient pharmacologic therapies for the treatment of diabetic neuropathy. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to placebo treatment in patients with diabetic neuropathy.', 'detailedDescription': 'Patients (n=80) with symptomatic diabetic neuropathy will be included into this randomized controlled trial. Each intervention will be administered for a period of at least 30 min on at leat 5 days in a week. Health impairments will be assessed using the neuropathy symptom score (NSS) before, during and after intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic diabetic neuropathy\n* stable oral analgesic regimen\n\nExclusion Criteria:\n\n* history of drug or alcohol abuse\n* cardiac pacemaker or defibrillator\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04593992', 'acronym': 'HTEMS-RCT', 'briefTitle': 'HTEMS Treatment of Diabetic Polyneuropathy', 'organization': {'class': 'OTHER', 'fullName': 'West German Center of Diabetes and Health'}, 'officialTitle': 'High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy', 'orgStudyIdInfo': {'id': 'HP study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HTEMS', 'description': 'High-tone external muscle stimulation 5 times within a week for 12 weeks', 'interventionNames': ['Device: HTEMS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo stimulation 5 times within a week for 12 weeks', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'HTEMS', 'type': 'DEVICE', 'otherNames': ['HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)'], 'description': 'high-tone external muscle stimulation', 'armGroupLabels': ['HTEMS']}, {'name': 'Placebo', 'type': 'DEVICE', 'otherNames': ['Placebo treatment'], 'description': 'Placebo stimulation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40591', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West German Center of Diabetes and Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'gbo Medizintechnik AG', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Stephan Martin', 'investigatorAffiliation': 'West German Center of Diabetes and Health'}}}}