MedTrace Logo

miRNAs in Critical Limb Ischemia (miRNACLI)

NCT06066268 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-04-30

No results posted yet for this study

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.

Conditions

  • Critical Limb Ischemia

Interventions

DIAGNOSTIC_TEST

Critical limb ischemia: analysis of RNAs

analysis of miRNA expression levels

DIAGNOSTIC_TEST

Controls: analysis of RNAs

analysis of miRNAs expression levels

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Principal Investigators

  • Fabio Martelli · IRCCS Policlinico S. Donato

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06066268 on ClinicalTrials.gov