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

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

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.

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