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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.
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:
Any adverse events will be judged by an independent blinded committee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| data and specimen collection | consecutive diabetic patients admitted to Maria Cecilia Hospital for critical limb ischemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| data and specimen collection | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of amputation | Occurrence of major or minor amputation | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | occurrence of wound healing | 1-year |
| Change in WIfI class | 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 | Description | Time Frame |
|---|---|---|
| Incidence of major cardio and cerebrovascular adverse events (MACCE) | cumulative occurrence of all-cause death, myocardial infarction, cerebrovascular accident | 1-year |
Inclusion Criteria:
Exclusion Criteria:
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patients with diabetes mellitus and critical limb ischemia admitted to hospital for medical/interventional management of the disease
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| Name | Affiliation | Role |
|---|---|---|
| Luca Dalla Paola, MD | Maria Cecilia Hospital | Principal Investigator |
| Gianluca Campo, MD | Università degli Studi di Ferrara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Cecilia Hospital | Cotignola | Ravenna | 48010 | Italy |
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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
| 1-year |
| Change in Rutherford class | 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 | 1-year |
| Incidence of revascularization of peripheral arteries | any procedure (percutaneous or surgical) of revascularization of peripheral arteries | 1-year |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D000089802 | Chronic Limb-Threatening Ischemia |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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