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

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.