DiabetesNCT01269580
Diabetic Foot and Vascular Progenitor Cells
An observational study of Diabetes and Critical Limb Ischemia, run by IRCCS Multimedica at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Critical Limb Ischemia
- How many people
- 122 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2009to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients with peripheral ischemia
Who may be able to join
- 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)
Who cannot join
- Cancer with adverse prognosis in months, or chemotherapic treatment
- Ongoing or planned pregnancy
- Lack of consent to participate to the study
Trial locations and contacts
1 site in 1 country.
Italy1 site
Diabetic Foot Center IRCCS MultiMedica
Sesto San Giovanni, Milan, 20099
About this study
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.
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.
Read more
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.
Read the 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
- Conditions
- Diabetes, Critical Limb Ischemia
- Medical subject headings
- Diabetes Mellitus, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
post revascularization cardiovascualr mortality
Measured: 18 months
Secondary outcomes (1)
post revascularization amputation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startFeb 2009
- Primary completionJun 2013
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Multimedica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezio Faglia, MD, Principal investigator, IRCCS Multimedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269580
- Sponsor's protocol ID
- 20/2008_Cardiovascolare
- Status last verified
- Aug 2013
- First submitted
- 3 Jan 2011
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24574344
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01269580
- Acronym / sponsor ID
- 20/2008_Cardiovascolare
- Conditions
- Diabetes, Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (actual)
- Lead sponsor
- IRCCS MultimedicaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients with peripheral ischemia
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Cancer with adverse prognosis in months, or chemotherapic treatment
- Ongoing or planned pregnancy
- Lack of consent to participate to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post revascularization cardiovascualr mortality
Time frame: 18 months
1 secondary outcome
post revascularization amputation
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Derived from this study: PubMed 24574344Spinetti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezio Faglia, MD principal investigator
IRCCS Multimedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Critical Limb Ischemia, run by IRCCS Multimedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post revascularization cardiovascualr mortality (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01269580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.