No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
40 – 85
Sex
Any
Study type
Observational
Participants needed
80 (estimated)
Sponsor
IRCCS Policlinico S. Donato · Other
Who this trial is looking for
This trial is looking for patients with critical limb ischemia who may need surgery or amputation. Participants will provide biopsies that researchers will use to study specific molecules related to their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with critical limb ischemia.
I am a candidate for popliteal exploration surgery or bypass.
I have irreversible ischemia or gangrene of the lower limb and may need amputation.
I have an infrarenal abdominal aortic aneurysm and am undergoing surgery for it.
You may not be able to join if
I am pregnant.
I have a genetic disease.
I have cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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. Th…
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.
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.
Trial Locations
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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:
…
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
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