NCT06066268 miRNAs in Critical Limb Ischemia (miRNACLI)
| NCT ID | NCT06066268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Policlinico S. Donato |
| Condition | Critical Limb Ischemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2016-05-31 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2016-05-31 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Fabio Martelli
PRINCIPAL INVESTIGATOR
IRCCS Policlinico S. Donato
Frequently Asked Questions
Who can join the NCT06066268 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Critical Limb Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06066268 currently recruiting?
Yes, NCT06066268 is actively recruiting participants. Contact the research team at fabio.martelli@grupposandonato.it for enrollment information.
Where is the NCT06066268 trial being conducted?
This trial is being conducted at San Donato Milanese, Italy.
Who is sponsoring the NCT06066268 clinical trial?
NCT06066268 is sponsored by IRCCS Policlinico S. Donato. The principal investigator is Fabio Martelli at IRCCS Policlinico S. Donato. The trial plans to enroll 80 participants.