Clinical trial NCT03636867: Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Critical Limb Ischemia
Critical Lower Limb Ischemia
Diabetic Foot
Lead sponsor: Maria Cecilia Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of amputation
timeFrame: 1-year
Secondary outcomes:
measure: Wound healing
timeFrame: 1-year
measure: Change in WIfI class
timeFrame: 1-year
measure: Change in Rutherford class
timeFrame: 1-year
measure: Incidence of revascularization of peripheral arteries
timeFrame: 1-year
Other outcomes:
measure: Incidence of major cardio and cerebrovascular adverse events (MACCE)
timeFrame: 1-year
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
Study officials:
affiliation: Maria Cecilia Hospital
name: Luca Dalla Paola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Ferrara
name: Gianluca Campo, MD
role: PRINCIPAL_INVESTIGATOR
References: