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Limb Salvage in Diabetic Patients with No-Option Critical Limb Ischemia: Outcomes of a Single Center Experience

29 Pages Posted: 24 Jan 2019

See all articles by Luca Dalla Paola

Luca Dalla Paola

GVM Care & Research - Diabetic Foot Department; University of Ferrara - Cardiovascular Center

Paolo Cimaglia

GVM Care & Research - Maria Cecilia Hospital; University of Ferrara - Cardiovascular Center

Anna Carone

GVM Care & Research - Maria Cecilia Hospital

Giuseppe Scavone

GVM Care & Research - Maria Cecilia Hospital

Giulio Boscarino

GVM Care & Research - Maria Cecilia Hospital

Davide Bernucci

University of Ferrara - Cardiovascular Center

Paolo Sbarzaglia

GVM Care & Research - Maria Cecilia Hospital

Stefano Censi

GVM Care & Research - Maria Cecilia Hospital

Roberto Ferrari

GVM Care & Research - Maria Cecilia Hospital; University of Ferrara - Cardiovascular Center

Gianluca Campo

GVM Care & Research - Maria Cecilia Hospital; University of Ferrara - Cardiovascular Center

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Abstract

Objective: To describe the characteristics, the management and the outcome of a consecutive series of patients with diabetic foot (DF) and no-option critical limb ischemia (CLI) treated with a multidimensional, interdisciplinary approach in a dedicated center.  

Research Design and Methods: The prospective database of the Diabetic Foot Unit of the Maria Cecilia Hospital (Cotignola, Italy) collects medical history, risk factors, chemistry values, angiographic data, characteristic of foot lesions, medical and surgical therapies of all patients admitted with diagnosis of DF and CLI. All patients were followed-up for at least one year and/or total recovery. The primary endpoint was one-year amputation-free survival (AFS), secondary endpoints were limb salvage and survival.  

Results: Between October 2014 and October 2017, 1024 patients with DF and CLI were admitted to the center. Eighty-four of them (8.2%) fulfilled the criteria for no-option CLI. At one year, AFS, limb salvage, and survival rates were 34%, 34% and 83%, respectively. Lesions located proximal to Lisfranc joint were associated with major amputation (HR 2.1 [1.2-3.6]). One-year survival of patients treated with minor procedures was significantly higher compared to patients treated with major amputation (96% vs 76%, log rank p=0.019). Major amputation was independently associated with mortality (HR 7.83 [1.02-59.89]).  

Conclusions: The application of dedicated and standardized strategies permitted limb salvage in one-third of patients with no-option CLI. Patients with stable lesions limited to the forefoot and without ischaemic pain had greater probability to successfully receive conservative treatments. Limb salvage was associated with subsequent higher one-year survival.  

Funding Statement: The authors declare: "None."

Declaration of Interests: The authors report no relationships that could be construed as a conflict of interest.

Ethics Approval Statement: Clinical and procedural data from all patients admitted to Diabetic Foot Unit of the Maria Cecilia Hospital (Cotignola, Italy) are recorded in a dedicated clinical database and accurately verified for completeness and accuracy against the patients’ clinical charts. Patients are prospectively followed up for at least 12 months. The analysis was based on current clinical practice, therefore the regulatory authorities required an ordinary written informed consent to procedures and data collection, which was obtained from all patients. The protocol of the study was in accordance with the Declaration of Helsinki.

Suggested Citation

Dalla Paola, Luca and Cimaglia, Paolo and Carone, Anna and Scavone, Giuseppe and Boscarino, Giulio and Bernucci, Davide and Sbarzaglia, Paolo and Censi, Stefano and Ferrari, Roberto and Campo, Gianluca, Limb Salvage in Diabetic Patients with No-Option Critical Limb Ischemia: Outcomes of a Single Center Experience (January 20, 2019). Available at SSRN: https://ssrn.com/abstract=3320178

Luca Dalla Paola (Contact Author)

GVM Care & Research - Diabetic Foot Department ( email )

Italy

University of Ferrara - Cardiovascular Center

Cona
Italy

Paolo Cimaglia

GVM Care & Research - Maria Cecilia Hospital

Italy

University of Ferrara - Cardiovascular Center

Cona
Italy

Anna Carone

GVM Care & Research - Maria Cecilia Hospital

Italy

Giuseppe Scavone

GVM Care & Research - Maria Cecilia Hospital

Italy

Giulio Boscarino

GVM Care & Research - Maria Cecilia Hospital

Italy

Davide Bernucci

University of Ferrara - Cardiovascular Center

Cona
Italy

Paolo Sbarzaglia

GVM Care & Research - Maria Cecilia Hospital

Italy

Stefano Censi

GVM Care & Research - Maria Cecilia Hospital

Italy

Roberto Ferrari

GVM Care & Research - Maria Cecilia Hospital

Italy

University of Ferrara - Cardiovascular Center

Cona
Italy

Gianluca Campo

GVM Care & Research - Maria Cecilia Hospital

Italy

University of Ferrara - Cardiovascular Center

Cona
Italy

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