Examining microRNAs in patients with Critical Limb Ischemia
Role of microRNAs in Critical Limb Ischemia
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 |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milan) |
| Trial ID | NCT06066268 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with critical limb ischemia who are undergoing surgical interventions such as bypass or amputation.
Not a fit: Patients with genetic diseases, malignant neoplasia, or those who are pregnant will not benefit from this study.
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 performed: While the specific approach of analyzing microRNAs in CLI is novel, similar studies in other conditions have shown promising results.
Eligibility criteria
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 this trial is running
San Donato Milanese, Milan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.