Diabetes MellitusECAD-CLINCT03636867
Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia
An observational study of Diabetes Mellitus and Critical Limb Ischemia, run by Maria Cecilia Hospital at 1 site in Italy.
Trial summary
The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in patients with diabetes mellitus and critical limb ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Critical Limb Ischemia, Critical Lower Limb Ischemia
- What is being tested?
- data and specimen collection
- How many people
- 236 participants
- Where
- 1 siteItaly
- Study dates
- 7 Aug 2018to 31 Aug 2020
- How long will I take part?
- 5 Years
- 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: patients with diabetes mellitus and critical limb ischemia admitted to hospital for medical/interventional management of the disease
Who may be able to join
- diagnosis of diabetes mellitus in treatment with oral agents and/or insulin
- diagnosis of critical limb ischemia requiring medical and/or interventional treatment
Who cannot join
- dialysis
- diagnosis or suspicion of malignancy
- life expectancy <1 year
- inability to guarantee clinical follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Laboratory, Cellular and Molecular Determinants of Clinical Success of the Treatment in Diabetic Patients With Critical Limb Ischemia (ECAD-CLI) Study
The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in patients with diabetes mellitus and critical limb ischemia.
Read the detailed description
All consecutive patients admitted to Maria Cecilia Hospital will be enrolled in the ECAD-CLI study. According to interventional management of the patient the following data and samples will be prospectively collected and related to outcome:
- medical history, cardiovascular risk factors, clinical presentation
- information related to angiography of peripheral arteries. An independent core-lab will review angiographies to assess extent and severity of peripheral artery disease
- information related to medical treatment, including antithrombotic agents, antimicrobics and any treatment to permit wound healing
- blood sample to obtain DNA, RNA and serum
- patient undergoing surgery and/or debridement for wound/ulcer due to diabetic foot disease will receive biopsy for specimen collection
- atherosclerotic plaque sample in patients undergoing atherectomy for the treatment of the peripheral artery disease All clinical variables and information obtained from blood/tissue samples will be related to outcome.
Any adverse events will be judged by an independent blinded committee.
- Being tested
- data and specimen collection
- Medical subject headings
- Diabetes Mellitus, Chronic Limb-Threatening Ischemia, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data and specimen collectionOther
to identify laboratory, cellular and molecular determinants of clinical success after treatment, several clinical information and specimens will be collected by Authors from each patient
| Study group | Role | What they receive |
|---|---|---|
| data and specimen collection | consecutive diabetic patients admitted to Maria Cecilia Hospital for critical limb ischemia Receives: Other: data and specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of amputation
Occurrence of major or minor amputation
Measured: 1-year
Secondary outcomes (4)
Wound healing
occurrence of wound healing
Measured: 1-year
Change in WIfI class
The Wound, Ischemia and Foot Infection is the most used classification for patients with diabetic foot disease. The classification ranges from 0 to 9. The scale includes 3 items: wound extension, presence and severity of ischemia, presence and severity of ischemia. Each item ranges from 0 to 3 points.
Measured: 1-year
Change in Rutherford class
The Rutherford classification is the most used scale to stratify patients with peripheral artery disease. The classification ranges from class I to class VI. Patients with critical limb ischemia show a class from IV to VI. The Rutherford class will be assessed in all patients at baseline and 1-year after to estimate the presence or not of improvement
Measured: 1-year
Incidence of revascularization of peripheral arteries
any procedure (percutaneous or surgical) of revascularization of peripheral arteries
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start7 Aug 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Dalla Paola, MD, Principal investigator, Maria Cecilia HospitalGianluca Campo, MD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636867
- Sponsor's protocol ID
- 5510/2018
- Acronym
- ECAD-CLI
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2018
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Laboratory, Cellular and Molecular Determinants of Clinical Success of the Treatment in Diabetic Patients With Critical Limb Ischemia (ECAD-CLI) Study
- ClinicalTrials.gov ID
- NCT03636867
- Acronym / sponsor ID
- ECAD-CLI / 5510/2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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.
The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in patients with diabetes mellitus and critical limb ischemia.
Detailed description
All consecutive patients admitted to Maria Cecilia Hospital will be enrolled in the ECAD-CLI study. According to interventional management of the patient the following data and samples will be prospectively collected and related to outcome:
- medical history, cardiovascular risk factors, clinical presentation
- information related to angiography of peripheral arteries. An independent core-lab will review angiographies to assess extent and severity of peripheral artery disease
- information related to medical treatment, including antithrombotic agents, antimicrobics and any treatment to permit wound healing
- blood sample to obtain DNA, RNA and serum
- patient undergoing surgery and/or debridement for wound/ulcer due to diabetic foot disease will receive biopsy for specimen collection
- atherosclerotic plaque sample in patients undergoing atherectomy for the treatment of the peripheral artery disease All clinical variables and information obtained from blood/tissue samples will be related to outcome.
Any adverse events will be judged by an independent blinded committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| data and specimen collection | – | Other: data and specimen collectionconsecutive diabetic patients admitted to Maria Cecilia Hospital for critical limb ischemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with diabetes mellitus and critical limb ischemia admitted to hospital for medical/interventional management of the disease
Key inclusion criteria (2 listed)
- diagnosis of diabetes mellitus in treatment with oral agents and/or insulin
- diagnosis of critical limb ischemia requiring medical and/or interventional treatment
Key exclusion criteria (4 listed)
- dialysis
- diagnosis or suspicion of malignancy
- life expectancy <1 year
- inability to guarantee clinical follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data and specimen collectionto identify laboratory, cellular and molecular determinants of clinical success after treatment, several clinical information and specimens will be collected by Authors from each patient | Other | data and specimen collection |
Primary outcome
Incidence of amputation
Time frame: 1-year
Occurrence of major or minor amputation
4 secondary outcomes
Wound healing
Time frame: 1-year
Change in WIfI class
Time frame: 1-year
Change in Rutherford class
Time frame: 1-year
Incidence of revascularization of peripheral arteries
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Luca Dalla Paola, MD principal investigator
Maria Cecilia Hospital
Gianluca Campo, MD principal investigator
Università degli Studi di Ferrara
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 Mellitus and Critical Limb Ischemia, run by Maria Cecilia Hospital 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 4 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: finished, as of the sponsor's last update on 24 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of amputation (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2023.