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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Donato Milanese, Milan, Italy
Patients applied
Trial Officials
Fabio Martelli
Principal Investigator
IRCCS Policlinico S. Donato
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported