Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT05165758
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2021-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D048909', 'term': 'Diabetes Complications'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the levels of quality of life in diabetic subjects with and without foot ulcer', 'timeFrame': '6 months', 'description': 'The primary endpoint will be the score on the mental health dimension of the SF-36 score'}], 'secondaryOutcomes': [{'measure': 'Compare the levels of precarity in diabetic subjects with and without foot ulcer', 'timeFrame': '6 months', 'description': 'To evaluate the level of precarity, the EPICES score will be calculated for both type of subjects.'}, {'measure': 'Compare the levels of quality of life according to the levels of HbA1c, in diabetic subjects with and without foot ulcer', 'timeFrame': '6 months', 'description': 'To evaluate the level of quality of life according to HbA1c, the score of the mental health dimension of the SF-36 questionnaire will be calculated for both type of subjects.'}, {'measure': 'Compare the quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer', 'timeFrame': '6 months', 'description': 'To evaluate the level of quality of life according to the duration of diabetes, the score of the mental health dimension of the SF-36 questionnaire will be calculated for both type of subjects.'}, {'measure': 'Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer', 'timeFrame': '6 months', 'description': 'To evaluate the level of quality of life according to the antidiabetic treatment, the score of the mental health dimension of the SF-36 questionnaire will be calculated for both type of subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabete', 'Diabete complications', 'Diabetic foot ulcer', 'socio-economic disparities'], 'conditions': ['Diabetes', 'Diabetes Mellitus', 'Foot Ulcer, Diabetic', 'Diabetes Complications']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare quality of life of diabetics with and without foot ulcer. Investigators will compare their quality of life based on the mental health impact of foot ulcer.', 'detailedDescription': 'Diabetes is one of the most frequent pathologies in Martinique (French West Indies) in terms of prevalence, as are its complications. The diabetic foot ulcer is a real public health problem considering its impact on the island.\n\nIt has already been shown that diabetic patients have a lower quality of life than the overall population. It is now time to compare the quality of life of diabetics with and without foot ulcer in Martinique.\n\nSuch a complication has a social impact that should not be overlooked in primary, secondary and tertiary prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic subjects', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People of 18 years old and over,\n* Diabetics living in Martinique,\n* Patient having been informed of the research,\n* Patient agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Minor patient,\n* Hospitalized patients during inclusion phase,\n* Patients with confusional syndrome,\n* Patient presenting a cognitive state making it difficult to complete the questionnaire,\n* Patient under legal protection, under guardianship or under curatorship,\n* Patient who refused to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05165758', 'acronym': 'QVP-Dia', 'briefTitle': 'Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Center of Martinique'}, 'officialTitle': 'Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique', 'orgStudyIdInfo': {'id': '21_RIPH3-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic subjects without foot ulcer', 'description': "27 diabetic subjects without foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé)", 'interventionNames': ['Other: Self-assessment questionnaires']}, {'label': 'Diabetic subjects with foot ulcer', 'description': "54 diabetic subjects presenting foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé)", 'interventionNames': ['Other: Self-assessment questionnaires']}], 'interventions': [{'name': 'Self-assessment questionnaires', 'type': 'OTHER', 'description': 'Subjects will pass the SF-36 score (mental health items) and the EPICES index', 'armGroupLabels': ['Diabetic subjects with foot ulcer', 'Diabetic subjects without foot ulcer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97261', 'city': 'Fort-de-France', 'state': 'Martinique', 'country': 'France', 'facility': 'University Hospital Center of Martinique'}], 'overallOfficials': [{'name': 'Miguel BOURGADE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Center of Martinique'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Center of Martinique', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}