Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-04-23 @ 3:36 AM
Study NCT ID:
NCT05123157
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate and Pattern of amputation.', 'timeFrame': '7 years', 'description': 'identify how many patients with Diabetic foot underwent amputation, and what type of amputation (major or minor)'}, {'measure': 'Mortality among patients with diabetic foot', 'timeFrame': '7 years', 'description': '7-years mortality rate and predictive variable of death among patients with Diabetic foot.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Foot', 'Amputation']}, 'descriptionModule': {'briefSummary': 'This study explored the pattern and type of amputations performed on patients with diabetic foot who were admitted to our institution, as well as the 7-year mortality rate of patients with diabetic foot at the same institution. We believe that our study makes a significant contribution to the literature because it highlights the need for strengthening efforts to decrease the risk of amputation and mortality among patients with diabetic foot, especially in Jeddah, Saudi Arabia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'medical records of King Abdulaziz University Hospital (KAUH).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* From the medical records of King Abdulaziz University Hospital (KAUH).\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05123157', 'briefTitle': 'Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': 'Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '465- 20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NO intervention', 'type': 'OTHER', 'description': 'N/:\n\nNO intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80502', 'city': 'Jeddah', 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Abdullah Abdulaziz Almohammadi', 'investigatorAffiliation': 'King Abdulaziz University'}}}}