Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-20 @ 10:46 PM
Study NCT ID:
NCT03636867
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}, {'id': 'D017719', 'term': 'Diabetic Foot'}], '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': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'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': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'for each patient, according clinical presentation and type of intervention, the Authors will collect: i) blood sample for DNA extraction, RNA extraction and serum collection; plaque from patients undergoing endoarterectomy, tissue removed from foot ulcers requiring debridement or surgical manipulation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of major cardio and cerebrovascular adverse events (MACCE)', 'timeFrame': '1-year', 'description': 'cumulative occurrence of all-cause death, myocardial infarction, cerebrovascular accident'}], 'primaryOutcomes': [{'measure': 'Incidence of amputation', 'timeFrame': '1-year', 'description': 'Occurrence of major or minor amputation'}], 'secondaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': '1-year', 'description': 'occurrence of wound healing'}, {'measure': 'Change in WIfI class', 'timeFrame': '1-year', 'description': 'The Wound, Ischemia and Foot Infection is the most used classification for patients with diabetic foot disease. The classification ranges from 0 to 9. The scale includes 3 items: wound extension, presence and severity of ischemia, presence and severity of ischemia. Each item ranges from 0 to 3 points.'}, {'measure': 'Change in Rutherford class', 'timeFrame': '1-year', 'description': 'The Rutherford classification is the most used scale to stratify patients with peripheral artery disease. The classification ranges from class I to class VI. Patients with critical limb ischemia show a class from IV to VI. The Rutherford class will be assessed in all patients at baseline and 1-year after to estimate the presence or not of improvement'}, {'measure': 'Incidence of revascularization of peripheral arteries', 'timeFrame': '1-year', 'description': 'any procedure (percutaneous or surgical) of revascularization of peripheral arteries'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Critical Limb Ischemia', 'Critical Lower Limb Ischemia', 'Diabetic Foot']}, 'descriptionModule': {'briefSummary': 'The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in patients with diabetes mellitus and critical limb ischemia.', 'detailedDescription': 'All consecutive patients admitted to Maria Cecilia Hospital will be enrolled in the ECAD-CLI study. According to interventional management of the patient the following data and samples will be prospectively collected and related to outcome:\n\n* medical history, cardiovascular risk factors, clinical presentation\n* information related to angiography of peripheral arteries. An independent core-lab will review angiographies to assess extent and severity of peripheral artery disease\n* information related to medical treatment, including antithrombotic agents, antimicrobics and any treatment to permit wound healing\n* blood sample to obtain DNA, RNA and serum\n* patient undergoing surgery and/or debridement for wound/ulcer due to diabetic foot disease will receive biopsy for specimen collection\n* atherosclerotic plaque sample in patients undergoing atherectomy for the treatment of the peripheral artery disease All clinical variables and information obtained from blood/tissue samples will be related to outcome.\n\nAny adverse events will be judged by an independent blinded committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with diabetes mellitus and critical limb ischemia admitted to hospital for medical/interventional management of the disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of diabetes mellitus in treatment with oral agents and/or insulin\n* diagnosis of critical limb ischemia requiring medical and/or interventional treatment\n\nExclusion Criteria:\n\n* dialysis\n* diagnosis or suspicion of malignancy\n* life expectancy \\<1 year\n* inability to guarantee clinical follow-up'}, 'identificationModule': {'nctId': 'NCT03636867', 'acronym': 'ECAD-CLI', 'briefTitle': 'Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Maria Cecilia Hospital'}, 'officialTitle': 'Prospective Evaluation of Laboratory, Cellular and Molecular Determinants of Clinical Success of the Treatment in Diabetic Patients With Critical Limb Ischemia (ECAD-CLI) Study', 'orgStudyIdInfo': {'id': '5510/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'data and specimen collection', 'description': 'consecutive diabetic patients admitted to Maria Cecilia Hospital for critical limb ischemia', 'interventionNames': ['Other: data and specimen collection']}], 'interventions': [{'name': 'data and specimen collection', 'type': 'OTHER', 'description': 'to identify laboratory, cellular and molecular determinants of clinical success after treatment, several clinical information and specimens will be collected by Authors from each patient', 'armGroupLabels': ['data and specimen collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48010', 'city': 'Cotignola', 'state': 'Ravenna', 'country': 'Italy', 'facility': 'Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}], 'overallOfficials': [{'name': 'Luca Dalla Paola, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maria Cecilia Hospital'}, {'name': 'Gianluca Campo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Ferrara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Cecilia Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}