Rizzo Loredana, Tedeschi Anna, Fallani Eliana, Coppelli Alberto, Vallini Valerio, Iacopi Elisabetta, Piaggesi Alberto
University of Pisa, Pisa, Italy.
Int J Low Extrem Wounds. 2012 Mar;11(1):59-64. doi: 10.1177/1534734612438729. Epub 2012 Feb 15.
The objective of this study was to assess the impact of a structured follow-up program on the incidence of diabetic foot ulceration (DFU) in high-risk diabetic patients.
A total of 1874 diabetic patients referred to the Diabetic Foot Unit of the University of Pisa were ranked based on the ulcerative risk score proposed by the International Consensus on Diabetic Foot. Out of 334 patients (17.8%) with a score ≥2, 298 accepted to participate in this prospective trial and were randomized into 2 groups: group A, which received standard treatment, and group B, in which the patients received, as a part of a structured prevention program, custom-made orthesis and shoes. Incidence of new DFUs was observed for no less than 1 year and in a subset of patients after 3 and 5 years, respectively. Incidence of new DFUs and recurrences were considered as primary endpoints to establish the effectiveness of the program; costs were also compared.
Among the patients enrolled in this follow-up analysis, 46% had neuropathy and deformities, 20% had previous ulceration, 25% had previous minor amputation, and 9% had neuro-osteoarthropathy. During the first 12-month follow-up, 11.5% of patients in group B developed a DFU compared with 38.6% in group A (P < .0001). In the extended follow-up, the cumulative incidence of ulcer in group B compared with group A was 17.6% versus 61% (P < .0001) after 3 years and 23.5% versus 72% (P < .0001) after 5 years, respectively. The net balance at the end of the follow-up was highly in favor of the prevention program, with a saving of more than €100 000 per year.
The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU in diabetic patients who are at high ulcerative risk and its related costs.
本研究的目的是评估结构化随访计划对高危糖尿病患者糖尿病足溃疡（DFU）发生率的影响。
共有1874名转诊至比萨大学糖尿病足病科的糖尿病患者，根据《糖尿病足国际共识》提出的溃疡风险评分进行排名。在334名（17.8%）评分≥2的患者中，298名接受参与这项前瞻性试验，并随机分为两组：A组接受标准治疗，B组患者作为结构化预防计划的一部分，接受定制的矫形器和鞋子。对新DFU的发生率进行了不少于1年的观察，部分患者分别在3年和5年后进行了观察。新DFU的发生率和复发率被视为确定该计划有效性的主要终点；同时还比较了成本。
参与此次随访分析的患者中，46%患有神经病变和畸形，20%曾有溃疡，25%曾有小截肢，9%患有神经骨关节病。在最初12个月的随访中，B组11.5%的患者发生了DFU，而A组为38.6%（P < .0001）。在延长随访中，B组与A组相比，3年后溃疡的累积发生率分别为17.6%和61%（P < .0001），5年后分别为23.5%和72%（P < .0001）。随访结束时的净结余非常有利于预防计划，每年节省超过10万欧元。
采用矫形器和鞋子进行结构化随访可降低溃疡高危糖尿病患者DFU的发生率及其相关成本。
