Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01269580
Study type Observational
Source IRCCS Multimedica
Contact
Status Active, not recruiting
Phase N/A
Start date February 2009
Completion date June 2015

See also
  Status Clinical Trial Phase
Completed NCT05594446 - Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
Completed NCT03975309 - DHS MIND Metabolomics
Completed NCT01855399 - Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes N/A
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Recruiting NCT05007990 - Caregiving Networks Across Disease Context and the Life Course
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Completed NCT04903496 - Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT03390179 - Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Recruiting NCT05294822 - Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes N/A
Completed NCT04427982 - Dance and Diabetes/Prediabetes Self-Management N/A
Completed NCT02356848 - STEP UP to Avert Amputation in Diabetes N/A
Completed NCT03292185 - A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects Phase 1
Active, not recruiting NCT05477368 - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4