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Completed

NCT Number: NCT03636867

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maria Cecilia Hospital

Cotignola, Ravenna, 48010, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Incidence of amputation

    Time frame: 1-year

    Occurrence of major or minor amputation

Secondary outcomes

  1. Wound healing

    Time frame: 1-year

    occurrence of wound healing

  2. Change in WIfI class

    Time frame: 1-year

    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.

  3. Change in Rutherford class

    Time frame: 1-year

    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

  4. Incidence of revascularization of peripheral arteries

    Time frame: 1-year

    any procedure (percutaneous or surgical) of revascularization of peripheral arteries

Other outcomes

  1. Incidence of major cardio and cerebrovascular adverse events (MACCE)

    Time frame: 1-year

    cumulative occurrence of all-cause death, myocardial infarction, cerebrovascular accident

Sponsors and collaborators

Lead sponsor

Maria Cecilia Hospital

Other

Registry information

Official study 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

Acronym: ECAD-CLI

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2018
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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