Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia (ECAD-CLI)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetic Foot; Critical Limb Ischemia; Critical Lower Limb Ischemia
• Intervention / Treatment: Other: data and specimen collection

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 Type: Observational
• Enrollment (Actual): 236

Contacts and Locations

• Study Contact: Name: Roberta Zoli; Phone Number: +39 0545217564; Email: direzionescientifica-mch@gvmnet.it
• Study Contact Backup: Name: Elena Tenti; Phone Number: +39 3391572707; Email: etenti@gvmnet.it

Study Locations

• Italy
  • Ravenna
    • Cotignola, Ravenna, Italy, 48010
      • Maria Cecilia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with diabetes mellitus and critical limb ischemia admitted to hospital for medical/interventional management of the disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
data and specimen collection; consecutive diabetic patients admitted to Maria Cecilia Hospital for critical limb ischemia	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of amputation	Occurrence of major or minor amputation	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	occurrence of wound healing	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.	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	1-year
Incidence of revascularization of peripheral arteries	any procedure (percutaneous or surgical) of revascularization of peripheral arteries	1-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major cardio and cerebrovascular adverse events (MACCE)	cumulative occurrence of all-cause death, myocardial infarction, cerebrovascular accident	1-year

Collaborators and Investigators

• Sponsor: Maria Cecilia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot; Ischemia
• Other Study ID Numbers: 5510/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No