Diabetes Clinical Trial
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.
Verified date | August 2013 |
Source | IRCCS Multimedica |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Observational |
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.
Objectives:
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.
Status | Active, not recruiting |
Enrollment | 122 |
Est. completion date | June 2015 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult diabetic patients type 1 or 2 - Chronic critical ischemia as defined by TASC 2007 criteria (pain at rest, and/or ulcer or gangrene due to artheropaty: transcutaneous oximetry < 30 mmHg or pressure on the ankle < 70 mmHg) Exclusion Criteria: - Cancer with adverse prognosis in months, or chemotherapic treatment - Ongoing or planned pregnancy - Lack of consent to participate to the study |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Diabetic Foot Center IRCCS MultiMedica | Sesto San Giovanni | Milan |
Lead Sponsor | Collaborator |
---|---|
IRCCS Multimedica |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | post revascularization restenosis | 18 months | No | |
Primary | post revascularization cardiovascualr mortality | 18 months | No | |
Secondary | post revascularization amputation | 18 months | No |
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