Diabetic Foot and Vascular Progenitor Cells

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
IRCCS Multimedica
ClinicalTrials.gov Identifier:
NCT01269580
First received: January 3, 2011
Last updated: August 7, 2013
Last verified: August 2013
  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
Critical Limb 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:


Further study details as provided by IRCCS Multimedica:

Primary Outcome Measures:
  • post revascularization cardiovascualr mortality [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • post revascularization amputation [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • post revascularization restenosis [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: February 2009
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by IRCCS Multimedica

Additional 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
Study First Received: January 3, 2011
Last Updated: August 7, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Diabetic Foot
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 October 19, 2014