Studying microRNAs in leg tissue of people with critical limb ischemia
Looks at microRNAs in tissue from 40 people with critical limb ischemia.
Key facts
- Who runs it
- IRCCS Policlinico S. Donato
- Where
- San Donato Milanese, ItalySee the site
- Trial code
- Registry title
- miRNAs in Critical Limb Ischemia (miRNACLI)
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 31 May 2016
- Expected to end
- 31 Jan 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- Critical limb ischemia: analysis of RNAs
- Controls: analysis of RNAs
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with critical limb ischemia (severe lack of blood flow in the leg) who are having bypass surgery or leg amputation. It also takes control patients with an abdominal aortic aneurysm having EVAR surgery, without limb ischemia.
- Age
- 40 Years to 85 Years
- Sex
- All
- Disease stage
- Cases: critical limb ischemia, planned for popliteal exploration surgery and/or subgenual femoropopliteal bypass, or irreversible ischemia and/or gangrene planned for major leg amputation. Controls: infrarenal abdominal aortic aneurysm treated with EVAR, free from critical limb ischemia, with or without type 2 diabetes.
Main reasons for not taking part
- Pregnant women
- People who carry genetic diseases
- People with cancer (malignant neoplasia)
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients carriers of genetic diseases
- Patients suffering from malignant neoplasia
- Pregnant women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 85 years old?
Where in Italy
- IRCCS Policlinico San DonatoSan Donato Milanese, ItalyContact: FABIO MARTELLI, PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- 1) Critical limb ischemia (CLI);
1)Critical limb ischemia (CLI): * Patients suffering from CLI undergoing lower limb revascularization via subgenual femoropopliteal bypass. muscle biopsies willbe taken. * Patients suffering from terminal CLI and/or gangrene of the lower limb undergoing thigh amputation. Muscle biopsies will be taken. * Patients suffering from terminal CLI and/or gangrene of the lower limb undergoing leg amputation. Muscle biopsies will be taken.
Treatment: Critical limb ischemia: analysis of RNAs
- 2)Controls
2)Controls: patients affected by infrarenal abdominal aortic aneurysm (AAA) free from CLI, affected and not affected by type 2 diabetes mellitus, undergoing endovascular exclusion surgery of the AAA (EVAR), similar by age and sex to CLI patients. Sartorius muscle biopsies will be taken.
Treatment: Controls: analysis of RNAs
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Role of microRNAs in Critical Limb Ischemia
- Plain-language title
- Studying microRNAs in leg tissue of people with critical limb ischemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06066268, who can take part
- Record updated
- 5 November 2026