Diabetic Foot and Vascular Progenitor Cells
Recruitment status was Active, not recruiting
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.
Critical Limb Ischemia
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|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.|
- post revascularization cardiovascualr mortality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- post revascularization amputation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- post revascularization restenosis [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||June 2015|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Adult diabetic patients type 1 or 2, with chronic critical ischemia as defined by TASC 2007 criteria
Adult not diabetic with chronic critical ischemia
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01269580
|Diabetic Foot Center IRCCS MultiMedica|
|Sesto San Giovanni, Milan, Italy, 20099|
|Principal Investigator:||Ezio Faglia, MD||IRCCS Multimedica|