RecruitingNCT06066268

miRNAs in Critical Limb Ischemia (miRNACLI)

Role of microRNAs in Critical Limb Ischemia

Sponsor

IRCCS Policlinico S. Donato

Enrollment

80 participants

Start Date

May 31, 2016

Study Type

OBSERVATIONAL

Conditions

Critical Limb Ischemia

Summary

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.

Eligibility

Min Age: 40 YearsMax Age: 85 Years

Inclusion Criteria5

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.