Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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: medical history, cardiovascular risk factors, clinical presentation information related to angiography of peripheral arteries. An independent core-lab will review angiographies to assess extent and severity of peripheral artery disease information related to medical treatment, including antithrombotic agents, antimicrobics and any treatment to permit wound healing blood sample to obtain DNA, RNA and serum patient undergoing surgery and/or debridement for wound/ulcer due to diabetic foot disease will receive biopsy for specimen collection 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. Any adverse events will be judged by an independent blinded committee.

Official Title
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Prospective Evaluation of Laboratory, Cellular and Molecular Determinants of Clinical Success of the Treatment in Diabetic Patients With Critical Limb Ischemia (ECAD-CLI) Study

Conditions
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Diabetes Mellitus, Critical Limb Ischemia, Critical Lower Limb Ischemia, Diabetic Foot

Intervention / Treatment
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* Other: data and specimen collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of diabetes mellitus in treatment with oral agents and/or insulin diagnosis of critical limb ischemia requiring medical and/or interventional treatment Exclusion Criteria: dialysis diagnosis or suspicion of malignancy life expectancy <1 year inability to guarantee clinical follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| data and specimen collection<br>consecutive diabetic patients admitted to Maria Cecilia Hospital for critical limb ischemia | Other: data and specimen collection<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of amputation | Occurrence of major or minor amputation | 1-year | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |