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

NCT03636867 | Completed DMC

• 1 other identifier: 5510/2018
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of amputation

  Occurrence of major or minor amputation

  1-year

Secondary Outcomes (4)

• Wound healing

  1-year

• Change in WIfI class

  1-year

• Change in Rutherford class

  1-year

• Incidence of revascularization of peripheral arteries

  1-year

Other Outcomes (1)

• Incidence of major cardio and cerebrovascular adverse events (MACCE)

  1-year

Study Arms (1)

data and specimen collection

consecutive diabetic patients admitted to Maria Cecilia Hospital for critical limb ischemia

Other: data and specimen collection

Interventions

data and specimen collection OTHER

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

data and specimen collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• diagnosis of diabetes mellitus in treatment with oral agents and/or insulin
• diagnosis of critical limb ischemia requiring medical and/or interventional treatment

You may not qualify if:

• dialysis
• diagnosis or suspicion of malignancy
• life expectancy \<1 year
• inability to guarantee clinical follow-up

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48010, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

for each patient, according clinical presentation and type of intervention, the Authors will collect: i) blood sample for DNA extraction, RNA extraction and serum collection; plaque from patients undergoing endoarterectomy, tissue removed from foot ulcers requiring debridement or surgical manipulation

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Limb-Threatening Ischemia; Diabetic Foot

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Luca Dalla Paola, MD

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

• Gianluca Campo, MD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: August 7, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: March 24, 2023

Record last verified: 2021-08

Locations

IT (1)