Diabetic Foot and Vascular Progenitor Cells

August 7, 2013 updated by: IRCCS Multimedica

The Diabetic Foot: Relevance of Vascular Progenitor Cells as a Prognostic Marker of Cardiovascular Mortality, Restenosis, and Atherosclerotic Disease Progression in Treated Limb.

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.

Study Overview

Status

Unknown

Detailed Description

This collaborative project aims to produce significant outputs for the identification of patients requiring intensification of therapy. Furthermore, the project will fill the gap in current knowledge on the post-genomic alterations that render diabetic vascular progenitor cells dysfunctional. In perspective, this might help us to design new therapies for the cure of the diabetic foot, including but not limited to stem cell therapy.

Primary Objectives:

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 Development of new atherosclerotic plaques in treated limb (follow up: 12 months).

Secondary Objectives:

To determine the mechanisms responsible for vascular progenitor cell dysfunction in the perspective of new therapies for the cure of the diabetic foot.

All the Units will contribute to the primary objective (to validate the prognostic value of vascular progenitor cells, identified by flow cytometric analysis of antigenic phenotype, in a cohort of 100 patients with type-2 diabetes complicated by ischemic foot ulcers). Furthermore, each Unit will focus on specific mechanistic targets, according to pilot data collected in previous and ongoing projects.

Dr Faglia, Head of the Diabetology Unit, Diabetic Foot Centre (IRCCS Multimedica-MM), will conduct the selection and enrollement of the patients, and collect all the clinical data for the study at the 12 month follow up visit.

The Unit leaded by Prof. Madeddu (IRCCS Multimedica), will perform the antigenic characterization of the vascular progenitor cells by flow cytometry, and conduct the migration assays.

The Unit leaded by Prof. Madeddu (IRCCS Multimedica)and the Unit leaded by Dr. Gaetano and Martelli (IDI, Rome) will be engaged with determining whether vascular progenitor cells dysfunction is mediated by specific epigenetic modifications. Epigenetics refers to the covalent modifications found in chromatin, on both the DNA and the accompanying histone proteins.

The Unit of Dr. Germani (IDI, Rome) will be focused on identification of growth factors, chemokines and cytokines in the serum of diabetic patients that could be involved in the deregulation of progenitor functions.

Since normal criteria are not already available, to conduct the analyses performed by the UO IDI, we need to enrol a group of 30 not-diabetic subjects age- and sex-matched to identify key changes to analyze in the entire group of patients.

Thirty patients coming to MM, UO Vascular Surgery, Dr Losa, for varicose vein treatment or carotid stenosis will be enrolled and subjected to blood withdrawal as described for the diabetic patients group.

Subject Inclusion Criteria:

Adult diabetic patients type 1 or 2, both men and women, with 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).

Subject Exclusion Criteria:

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

Patients enrolment

At this time all patients will undergo all the following exams:

  • General comprehensive visit (including: Chest RX, Rest ECG, and glycaemia plus glycosilated haemoglobin measurement)
  • Ankle arterial pressure (Doppler cw measurement)
  • Angiographyc study and angioplasty,if feasible, in the same time

IMPORTANT NOTE: At the enrolment visit and at follow up visit after 12 months will be performed:

  • Ecodoppler
  • Transcutaneous oximetry
  • Completion of antigenic profiling
  • Assessment of migratory capacity
  • Characterization of major epigenetic signatures
  • Paracrine profiling

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Milan
      • Sesto San Giovanni, Milan, Italy, 20099
        • Diabetic Foot Center IRCCS MultiMedica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Diabetic patients with peripheral ischemia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
post revascularization cardiovascualr mortality
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
post revascularization amputation
Time Frame: 18 months
18 months

Other Outcome Measures

Outcome Measure
Time Frame
post revascularization restenosis
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ezio Faglia, MD, IRCCS Multimedica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 7, 2013

Last Verified

August 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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