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Diabetic Foot and Vascular Progenitor Cells

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by IRCCS Multimedica.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
IDI, Via Monti di Creta 104 00167 Rome, Italy.
Information provided by:
IRCCS Multimedica
ClinicalTrials.gov Identifier:
NCT01269580
First received: January 3, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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
Diabetes
Chronic Critical Ischemia

Study Type: Observational
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS Multimedica:

Estimated Enrollment: 109
Study Start Date: February 2009
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269580

Contacts
Contact: Ezio Faglia, MD +30 02 2420 ext 9462 ezio.faglia@multimedica.it
Contact: Giacomo Clerici, MD +30 02 2420 ext 9466 giacomo.clerici@multimedica.it

Locations
Italy
Diabetic Foot Center IRCCS MultiMedica Recruiting
Sesto San Giovanni, Milan, Italy, 20099
Contact: Ezio Faglia, MD            
Contact: Giacomo Clerici, MD            
Sponsors and Collaborators
IRCCS Multimedica
IDI, Via Monti di Creta 104 00167 Rome, Italy.
  More Information

No publications provided

Responsible Party: Maurizio Capogrossi
ClinicalTrials.gov Identifier: NCT01269580     History of Changes
Other Study ID Numbers: 20/2008_Cardiovascolare
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013