miRNAs in Critical Limb Ischemia (miRNACLI)
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. B
| Condition(s) | Critical Limb Ischemia |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 |
| Who can participate | 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 |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Lead sponsor | IRCCS Policlinico S. Donato |
| Locations | San Donato Milanese, Milan, Italy |
| Start date | 2016-05-31 |
| NCT ID | NCT06066268 |
| Official listing | https://clinicaltrials.gov/study/NCT06066268 |