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: * 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.
Study Type
OBSERVATIONAL
Enrollment
236
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
Maria Cecilia Hospital
Cotignola, Ravenna, Italy
Incidence of amputation
Occurrence of major or minor amputation
Time frame: 1-year
Wound healing
occurrence of wound healing
Time frame: 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.
Time frame: 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
Time frame: 1-year
Incidence of revascularization of peripheral arteries
any procedure (percutaneous or surgical) of revascularization of peripheral arteries
Time frame: 1-year
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