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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
Sponsor:
Information provided by (Responsible Party):
IRCCS Multimedica

Brief Summary:

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.


Condition or disease
Diabetes Critical Limb Ischemia

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 122 participants
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.
Study Start Date : February 2009
Actual Primary Completion Date : June 2013
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Diabetic
Adult diabetic patients type 1 or 2, with chronic critical ischemia as defined by TASC 2007 criteria
Not diabetic
Adult not diabetic with chronic critical ischemia



Primary Outcome Measures :
  1. post revascularization cardiovascualr mortality [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. post revascularization amputation [ Time Frame: 18 months ]

Other Outcome Measures:
  1. post revascularization restenosis [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diabetic patients with peripheral ischemia
Criteria

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

Information from the National Library of Medicine

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


Locations
Italy
Diabetic Foot Center IRCCS MultiMedica
Sesto San Giovanni, Milan, Italy, 20099
Sponsors and Collaborators
IRCCS Multimedica
Investigators
Principal Investigator: Ezio Faglia, MD IRCCS Multimedica

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IRCCS Multimedica
ClinicalTrials.gov Identifier: NCT01269580     History of Changes
Other Study ID Numbers: 20/2008_Cardiovascolare
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Ischemia
Diabetic Foot
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies