Diabetic Foot and Vascular Progenitor Cells
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|ClinicalTrials.gov Identifier: NCT01269580|
Recruitment Status : Unknown
Verified August 2013 by IRCCS Multimedica.
Recruitment status was: Active, not recruiting
First Posted : January 4, 2011
Last Update Posted : August 9, 2013
Type of Study: Pilot Study monocenter Study Duration: 18 months Subject Participation Duration: The patients are enrolled for the time of the blood withdrawl.
Follow up visit will be after 12 months from the enrollement.
The project will have two major objectives:
A)To validate the prognostic value of vascular progenitor cells, identified by flow cytometric analysis of antigenic phenotype, in a cohort of 109 patients with type-2 diabetes complicated by ischemic foot ulcers. Events are: cardiovascular mortality, major amputation, post-angioplasty restenosis , and development of new atherosclerotic plaques in treated limb B)To determine the mechanisms responsible for vascular progenitor cell dysfunction in the perspective of new therapies for the cure of the diabetic foot.
|Condition or disease|
|Diabetes Critical Limb Ischemia|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||122 participants|
|Observational Model:||Case Control|
|Official Title:||The Diabetic Foot: Relevance of Vascular Progenitor Cells as a Prognostic Marker of Cardiovascular Mortality, Restenosis, and Atherosclerotic Disease Progression in Treated Limb.|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2015|
Adult diabetic patients type 1 or 2, with chronic critical ischemia as defined by TASC 2007 criteria
Adult not diabetic with chronic critical ischemia
- post revascularization cardiovascualr mortality [ Time Frame: 18 months ]
- post revascularization amputation [ Time Frame: 18 months ]
- post revascularization restenosis [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269580
|Diabetic Foot Center IRCCS MultiMedica|
|Sesto San Giovanni, Milan, Italy, 20099|
|Principal Investigator:||Ezio Faglia, MD||IRCCS Multimedica|