Dalla Paola Luca, Cimaglia Paolo, Carone Anna, Boscarino Giulio, Scavone Giuseppe
Maria Cecilia Hospital, Cotignola, Ravenna, Italy.
Int J Low Extrem Wounds. 2021 Jun;20(2):128-134. doi: 10.1177/1534734620905741. Epub 2020 Feb 14.
We have analyzed in a retrospective study of consecutive diabetic patients affected by no-option critical limb ischemia (CLI) the efficacy of the dermal substitute Integra Dermal Regeneration Template for treatment of complicated foot lesions. The primary end point was limb salvage and 1-year amputation-free survival. The secondary end point was healing time of surgical site. Between October 2014 and October 2017, 1024 patients with diabetic foot ulcer (DFU) and CLI were admitted. In 84 patients (8.2%), there was a failure in distal revascularization with a persistent CLI after the procedure. Despite the persistent CLI, a group of 26 patients of this cohort obtained complete wound healing. Among them, 13 patients were treated with surgical debridement or open amputations and application of dermal substitute Integra Dermal Regeneration Template and the other 13 patients were treated without any dermal substitute. The Integra group healed within a mean time of 83.5 days, and the control group healed within a mean of 139 days ( = .028). No major amputation was carried out at 1-year follow-up in the Integra group versus 15% in the control group. A conservative foot surgery or an approach with minor amputation in diabetic patients with no-option CLI may achieve limb salvage. The use of Integra Dermal Regeneration Template in patients with DFU and no-option CLI may be a useful option in a limb salvage program.
我们在一项针对连续性糖尿病患者的回顾性研究中分析了真皮替代物Integra真皮再生模板治疗复杂足部病变的疗效，这些患者均患有无可选择的严重肢体缺血（CLI）。主要终点是肢体挽救和1年无截肢生存率。次要终点是手术部位的愈合时间。2014年10月至2017年10月期间，收治了1024例糖尿病足溃疡（DFU）合并CLI患者。84例（8.2%）患者术后远端血管重建失败，仍存在持续性CLI。尽管存在持续性CLI，但该队列中有26例患者实现了伤口完全愈合。其中，13例患者接受了手术清创或开放性截肢，并应用了真皮替代物Integra真皮再生模板，另外13例患者未使用任何真皮替代物进行治疗。Integra组平均在83.5天内愈合，而对照组平均在139天内愈合（P = 0.028）。Integra组在1年随访时未进行大截肢，而对照组为15%。对于无可选择的CLI糖尿病患者，采用保守性足部手术或小截肢方法可能实现肢体挽救。在DFU合并无可选择的CLI患者中使用Integra真皮再生模板可能是肢体挽救计划中的一个有用选择。
