An observational study in Critical Limb Ischemia, sponsored by IRCCS Policlinico S. Donato. Recruiting at 1 site in Italy. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by IRCCS Policlinico S. Donato · Observational
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.
The analyzes of the expression of miRNAs and the RISC complex will be carried out on fragments of skeletal muscle taken from different sites depending on whether they are cases or controls.
Cases:
Controls:
The analyzes of the expression of circulating miRNAs will be carried out on 2 7 ml tubes of peripheral venous blood, taken before the surgical incision from the same cases and controls described in the previous point.
343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.
This study's planned enrollment of 80 is below the median of 123 across 98 observational studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →IRCCS Policlinico S. Donato is the lead sponsor of 101 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critical limb ischemia patients
Cases:
Controls:
Exclusion Criteria:
1)Critical limb ischemia (CLI): * Patients suffering from CLI undergoing lower limb revascularization via subgenual femoropopliteal bypass. muscle biopsies willbe taken. * Patients suffering from terminal CLI and/or gangrene of the lower limb undergoing thigh amputation. Muscle biopsies will be taken. * Patients suffering from terminal CLI and/or gangrene of the lower limb undergoing leg amputation. Muscle biopsies will be taken.
Diagnostic Test: Critical limb ischemia: analysis of RNAs
2)Controls: patients affected by infrarenal abdominal aortic aneurysm (AAA) free from CLI, affected and not affected by type 2 diabetes mellitus, undergoing endovascular exclusion surgery of the AAA (EVAR), similar by age and sex to CLI patients. Sartorius muscle biopsies will be taken.
Diagnostic Test: Controls: analysis of RNAs
analysis of miRNA expression levels
analysis of miRNAs expression levels
Identification of potentially pathogenic miRNAs in CLI and related target mRNAs.
Identify miRNAs and their targets that directly interact with the RNA Induced Silencing Complex (RISC) in muscle biopsies obtained from CLI patients.
Time frame: 1 year to 10 years
Identification of disease biomarkers
Identify plasma miRNAs to be used as disease biomarkers that can be used to assess disease status and severity with a minimally invasive procedure.
Time frame: 1 year to 10 years
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Chronic Limb-Threatening Ischemia→
IRCCS Policlinico S. Donato