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RECRUITINGOBSERVATIONAL

miRNAs in Critical Limb Ischemia (miRNACLI)

Role of microRNAs in Critical Limb Ischemia

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

For the present study, 40 patients affected by critical limb ischemia of different severity will be enrolled: patients affected by critical limb ischemia undergoing subgenual femoropopliteal bypass; patients suffering from terminal ischemia causing gangrene and therefore undergoing major amputation of the lower limb. Biopsies from the first 20 enrolled patients will be used for miRNA profiling. The total of 40 biopsies obtained from all enrolled patients will instead be used for the validation of the miRNAs identified in the profiling. The results obtained will be compared with those obtained in 40 control patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery (EVAR) of the AAA without any ischemia of the lower limbs. Also in this case the biopsies of the first 20 control patients enrolled will be used for miRNA profiling. The total of 40 biopsies obtained from all control patients will instead be used for the validation of the miRNAs identified in the profiling. A total of 80 patients (40 cases and 40 controls) will be enrolled.

Who May Be Eligible (Plain English)

Who May Qualify: Cases: - patients affected by CLI candidates for popliteal exploration surgery and/or subgenual femoropopliteal bypass. - Patients affected by CLI with irreversible ischemia and/or distal gangrene of the lower limb candidates for major amputation of the lower limb. Controls: • patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery of the AAA (EVAR) who are free from CLI, affected and not affected by type 2 diabetes mellitus. Who Should NOT Join This Trial: - Pregnant women - Patients carriers of genetic diseases - Patients suffering from malignant neoplasia Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Cases: * patients affected by CLI candidates for popliteal exploration surgery and/or subgenual femoropopliteal bypass. * Patients affected by CLI with irreversible ischemia and/or distal gangrene of the lower limb candidates for major amputation of the lower limb. Controls: • patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery of the AAA (EVAR) who are free from CLI, affected and not affected by type 2 diabetes mellitus. Exclusion Criteria: * Pregnant women * Patients carriers of genetic diseases * Patients suffering from malignant neoplasia

Treatments Being Tested

DIAGNOSTIC_TEST

Critical limb ischemia: analysis of RNAs

analysis of miRNA expression levels

DIAGNOSTIC_TEST

Controls: analysis of RNAs

analysis of miRNAs expression levels

Locations (1)

Irccs Policlinico San Donato
San Donato Milanese, Milan, Italy