Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT03539120
Status:
COMPLETED
Last Update Posted:
2018-05-29
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-amputation Survival Following Rehabilitation Medium and Long-term Follow up Study, a Retrospective Analysis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-25', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-05-25', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival in relation to time', 'timeFrame': '6 months to 6 years', 'description': 'Survival outcomes were analysed and have been included in the results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amputation']}, 'descriptionModule': {'briefSummary': 'This is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up.\n\nInvestigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions.', 'detailedDescription': 'Inclusion criteria: Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.\n\nExclusion criteria: Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study aimed to analyse survival outcome in patients with dysvascular lower limb amputation and identify relationship with existing comorbidities, i.e. diabetes mellitus (DM), peripheral vascular disease (PVD), ischaemic heart disease (IHD), estimated glomerular filtration rate (e-GFR), and chronic kidney disease (CKD). We also analysed the length of hospital stay, linear relationship with duration of DM, and vascular interventions.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients admitted for major dysvascular lower limb amputation, with complete follow-up record available.\n\nExclusion criteria:\n\nExclusion Criteria:\n\nTraumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records'}, 'identificationModule': {'nctId': 'NCT03539120', 'briefTitle': 'Post-amputation Survival Following Rehabilitation Medium and Long-term Follow up Study, a Retrospective Analysis.', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Prognosticating Outcomes in Stroke, Acquired Brain Injury, Amputee and Other Neurological Impairments', 'orgStudyIdInfo': {'id': '201511-00072'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Follow up for survival', 'type': 'OTHER', 'description': 'No intervention, this is an observational study of survival outcomes.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior consultant', 'investigatorFullName': 'Shrikant Pande', 'investigatorAffiliation': 'Changi General Hospital'}}}}