Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia

Diabetes Mellitus Clinical Trial

— ECAD-CLI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636867
• Other study ID #: 5510/2018
• Status: Completed
• Start date: August 7, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: August 2021
• Source: Maria Cecilia Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of diabetes mellitus in treatment with oral agents and/or insulin

• diagnosis of critical limb ischemia requiring medical and/or interventional treatment

Exclusion Criteria:

• dialysis

• diagnosis or suspicion of malignancy

• life expectancy <1 year

• inability to guarantee clinical follow-up

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Critical Lower Limb Ischemia
• Diabetes Mellitus
• Diabetic Foot
• Ischemia

Intervention

Other:
• data and specimen collection
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

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola	Ravenna

Sponsors (1)

Lead Sponsor	Collaborator
Maria Cecilia Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of major cardio and cerebrovascular adverse events (MACCE)	cumulative occurrence of all-cause death, myocardial infarction, cerebrovascular accident	1-year
Primary	Incidence of amputation	Occurrence of major or minor amputation	1-year
Secondary	Wound healing	occurrence of wound healing	1-year
Secondary	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.	1-year
Secondary	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	1-year
Secondary	Incidence of revascularization of peripheral arteries	any procedure (percutaneous or surgical) of revascularization of peripheral arteries	1-year