Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-01 @ 1:40 PM
Study NCT ID:
NCT05039957
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Fracture Ankle in Adults With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation , in Assiut University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-02', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '6 months', 'description': 'wound infection, hardware failure, Charcot arthropathy, development of ulcer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Figure Out the Best Method of Fixation for Management of Patients With Diabetic Fracture Ankle']}, 'descriptionModule': {'briefSummary': 'Diabetes is a well-known risk factor for complications following ankle fracture fixation.Current recommendations for operative treatment of ankle fractures in patients with diabetes consist of increased rigid fixation and prolonged periods of non-weight bearing with minimally invasive techniques.\n\nYee et al described a treatment algorithm for ankle fractures in diabetes patients based on the extent of their diabetic complications, Adelaide Fracture in the Diabetic Ankle (AFDA) score, and suggest that primary ankle arthrodesis may be an option in severe situations.\n\nEbaugh et.al. described the technique of fixing the ankle joint in diabetic patients without joint preparation .\n\nPrimary hindfoot arthrodesis with Calcaneotibial nail with formal joint preparation was described by many authors as treatment for ankle fractures in diabetic patient .\n\nTo our knowledge, there is no comparative study in management of ankle fractures in diabetic patients using these two different techniques.\n\nOur hypothesis is to try to prove that management of diabetic fracture ankle by hindfoot nail without joint preparation is better than other techniques regarding overall lower complication rate, higher functional outcome and better option for treatment of these patients using minimal invasive approaches in those high risk patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • All subjects aged 50y or more with recent fracture ankle (less than two weeks) with uncontrolled diabetes in form of high level of hemoglobinA1C ( \\>6.4% ) and/ or high random blood sugar level on admission (\\>200mg/dl). Patients with one or more complications due to diabetic e,g. neuropathy, nephropathy , and/or peripheral vascular disease.\n\nExclusion Criteria:\n\n* • Previous ankle fracture fixation in the same side.\n\n * Charcot arthropathy\n * Polytrauma, multiple skeletal injury.'}, 'identificationModule': {'nctId': 'NCT05039957', 'briefTitle': 'Management of Fracture Ankle in Adults With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation , in Assiut University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Management of Fracture Ankle in Patients With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation: Randomized Control Study', 'orgStudyIdInfo': {'id': '17200615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Other: joint preparation']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Other: without joint preparation']}], 'interventions': [{'name': 'joint preparation', 'type': 'OTHER', 'description': 'fixation of fracture with joint preparation', 'armGroupLabels': ['A']}, {'name': 'without joint preparation', 'type': 'OTHER', 'description': 'fixation of fracture without joint preparation', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'momen ayman, MD', 'role': 'CONTACT', 'email': 'm.ayman112@live.com', 'phone': '01119196610'}], 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'momen Ayman Fekry, MD', 'role': 'CONTACT', 'email': 'm.ayman112@live.com', 'phone': '+201119196610'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'momen ayman fekry', 'investigatorAffiliation': 'Assiut University'}}}}