Examining microRNAs in patients with Critical Limb Ischemia
Official title: Role of microRNAs in Critical Limb Ischemia
Run by IRCCS Policlinico S. Donato · NCT06066268 · Data updated 2026-11-12
This study is trying to see if certain tiny molecules in muscle tissue can help us understand critical limb ischemia better by comparing patients with this condition to those who have a different blood vessel issue.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years to 85 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milan) |
| Status | Recruiting |
| Started | May 31, 2016 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06066268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with critical limb ischemia who are undergoing surgical interventions such as bypass or amputation.
✕Probably not a fit
Patients with genetic diseases, malignant neoplasia, or those who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study enrolls 40 patients suffering from critical limb ischemia (CLI) to analyze the expression of microRNAs in skeletal muscle biopsies. Patients will be categorized based on the severity of their condition, with some undergoing bypass surgery and others facing major amputations. The results will be compared to a control group of 40 patients with infrarenal abdominal aortic aneurysm who do not have CLI. The study aims to identify and validate specific microRNAs that may play a role in CLI.
Why it matters
Potential benefit: If successful, this study could lead to new biomarkers for diagnosing and treating critical limb ischemia.
How similar studies have gone: While the specific approach of analyzing microRNAs in CLI is novel, similar studies in other conditions have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Irccs Policlinico San Donato
San Donato Milanese, Milan, Italy Recruiting
Study contacts
- Principal investigator: Fabio Martelli — IRCCS Policlinico S. Donato
- Study coordinator: Fabio Dr Martelli
- Email: fabio.martelli@grupposandonato.it
- Phone: +39 0226437762
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.