Diabetic Foot and Vascular Progenitor Cells

NCT01269580 | Unknown

• 1 other identifier: 20/2008_Cardiovascolare
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• post revascularization cardiovascualr mortality

  18 months

Secondary Outcomes (1)

• post revascularization amputation

  18 months

Other Outcomes (1)

• post revascularization restenosis

  18 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetic patients with peripheral ischemia

You may qualify if:

• 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)

You may not qualify if:

• Cancer with adverse prognosis in months, or chemotherapic treatment
• Ongoing or planned pregnancy
• Lack of consent to participate to the study

Sponsors & Collaborators

• IRCCS Multimedica: lead

Study Sites (1)

Diabetic Foot Center IRCCS MultiMedica

Sesto San Giovanni, Milan, 20099, Italy

Location

Related Publications (1)

• Spinetti G, Specchia C, Fortunato O, Sangalli E, Clerici G, Caminiti M, Airoldi F, Losa S, Emanueli C, Faglia E, Madeddu P. Migratory activity of circulating mononuclear cells is associated with cardiovascular mortality in type 2 diabetic patients with critical limb ischemia. Diabetes Care. 2014 May;37(5):1410-7. doi: 10.2337/dc13-2084. Epub 2014 Feb 26.

  PMID: 24574344 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Ezio Faglia, MD

  IRCCS Multimedica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: February 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2015
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

IT (1)