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Search / Trial NCT06066268

miRNAs in Critical Limb Ischemia (miRNACLI)

Launched by IRCCS POLICLINICO S. DONATO · Sep 27, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Micro Rna Ischemia

ClinConnect Summary

The miRNAs in Critical Limb Ischemia (miRNACLI) trial is studying a serious condition called critical limb ischemia (CLI), which causes severe pain and can lead to amputations in the legs due to poor blood flow. The study involves 80 patients: 40 with CLI who are undergoing surgery for their condition, and 40 who have a different issue (abdominal aortic aneurysm) but do not have CLI. Researchers will collect tissue samples from both groups of patients to analyze specific molecules called miRNAs, which may help understand the disease better and improve treatments in the future.

To be eligible, you must be an adult patient with CLI who is scheduled for surgery, or a patient with an abdominal aortic aneurysm who is undergoing a specific type of surgery and does not have CLI. Unfortunately, pregnant women, those with certain genetic diseases, or cancer patients cannot participate. If you join the study, you can expect to provide a biopsy, which is a small sample of tissue, to help researchers gather important information about your condition. This study is currently looking for participants, and being part of it may contribute to developing new ways to treat CLI.

Gender

ALL

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

About Irccs Policlinico S. Donato

IRCCS Policlinico S. Donato is a leading Italian research hospital and clinical trial sponsor dedicated to advancing medical science through innovative research and patient care. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it is recognized for its commitment to high-quality clinical research and the integration of scientific investigation with clinical practice. The institution specializes in various medical fields, including cardiology, oncology, and neurology, and collaborates with universities and research organizations to facilitate cutting-edge studies. With a focus on improving patient outcomes and contributing to public health, IRCCS Policlinico S. Donato plays a pivotal role in the development of new therapies and treatment protocols.

Locations

San Donato Milanese, Milan, Italy

Patients applied

0 patients applied

Trial Officials

Fabio Martelli

Principal Investigator

IRCCS Policlinico S. Donato

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported