Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT03555656
Status:
TERMINATED
Last Update Posted:
2021-01-14
First Post:
2018-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'whyStopped': 'Futility analysis suggested termination', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of foot ulcers', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of foot ulcers', 'timeFrame': '6 months'}, {'measure': 'incidence of foot ulcers', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Foot']}, 'descriptionModule': {'briefSummary': 'Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Either diabetic neuropathy or previous foot ulcer\n\nExclusion Criteria:\n\n* Arteriopathy of lower limbs, with ABI\\<0.8 or needing revascularization'}, 'identificationModule': {'nctId': 'NCT03555656', 'briefTitle': 'Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Careggi'}, 'officialTitle': 'Patient Education for the Prevention of Lower Limb Ulcers in Patients With Type 2 Diabetes: Validation of an Educational Intervention Repeated Every Three Months for 2 Years.', 'orgStudyIdInfo': {'id': 'PIEDE2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repeated educational intervention', 'description': 'Repetition every 6 months of a group educational session', 'interventionNames': ['Behavioral: Repeated intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Initial single group educational session, with no repetition', 'interventionNames': ['Behavioral: Single session']}], 'interventions': [{'name': 'Repeated intervention', 'type': 'BEHAVIORAL', 'description': 'Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention', 'armGroupLabels': ['Repeated educational intervention']}, {'name': 'Single session', 'type': 'BEHAVIORAL', 'description': 'Single 2-h group session educating patients at foot hygiene and ulcer prevention', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Diabetologia AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Diabetology', 'investigatorFullName': 'Edoardo Mannucci', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria Careggi'}}}}