Shear & Pressure Reducing Insoles for the Diabetic Foot

简介(由申请人提供)：我们会评估 SearSoleTM新型鞋垫，可减少脚部压力和剪切力。不是 商业上可用的鞋垫是为减少剪切而设计的。虽然保险 医疗服务提供者在糖尿病患者身上花费数百万美元？医用鞋垫，没有 关于切变或压力降低的科学数据。我们将评估最优的 第一阶段的粘结材料与使用相同材料的SearSole TM设计进行比较 粘弹性材料的组合。我们将评估两组150人的患者 在18个月的试验中，每支手臂的患者(总共300人)。对照组患者 手臂将穿上传统的粘合鞋垫，而另一只手臂将穿第二只手臂 收到SearSoleTM。在基线和18个月的试验结束时， 鞋内步态实验室和体外生物力学参数将测量压力， 剪切，以及材料特性，因为这些会随着磨损而变化。这是第二阶段 十八(18)个月的临床试验将评估 SearSoleTM可降低糖尿病溃疡的发生率。整体研究 假设SearSole TM将提供显著的剪切减少，因为 与传统鞋垫相比，不会牺牲压力降低 特性或耐用性。从长远来看，这项技术将是 可拆卸的石膏助行器(用于治疗溃疡)、轮椅坐垫 和床垫(以防止发生压疮)。 建议的商业应用：SearSole TM剪裁和压力释放鞋垫的低成本有望通过一种简单的程序将新的鞋垫放入他们的鞋子中，从而彻底改变糖尿病患者的护理。在一种新型的鞋垫包装中提供了剪切和压力释放的质量。这种简单的方法将有助于减少神经性溃疡、截肢和糖尿病发病率。实际上，SearSole TM应该成为糖尿病患者的鞋垫选择。

DESCRIPTION (provided by applicant): We will evaluate the feasibility of the ShearSoleTM novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear. Although insurance providers spend millions on diabetics? therapeutic insoles, there is no scientific data about shear or pressure reduction. We will evaluate the optimal bonded materials from Phase I compared to the ShearSole TM design using the same combination of viscoelastic materials. We will evaluate 2 patient groups of 150 patients per arm (300 total) in an 18 month trial. The control group patient arm will wear a traditional bonded insole whereas another the second arm will receive the ShearSoleTM. At baseline, and at the end of the 18 month trial, in-shoe gait lab and in vitro biomechanical parameters will measure pressure, shear, and material properties as these change with wear. This Phase II eighteen (18) month clinical trial will evaluate the effectiveness of ShearSoleTM reducing the incidence of diabetic ulcers. The overall study hypothesis is that ShearSole TM will provide significant shear reduction as compared to traditional insoles without sacrificing pressure reduction characteristics or durability. In the long-term, this technology will be incorporated into removable cast walkers (to heal ulcers), wheelchair cushions and mattress pads (to prevent development of decubitus ulcers). PROPOSED COMMERCIAL APPLICATION: The low cost of ShearSole TM shear and pressure relieving insole promises to revolutionize diabetic patient care via a simple procedure of weating novel insoles in their shoes. Shear and pressure relieving qualities are provided in a novel insole package. This simple means will serve to decrease neuropathic ulcers, amputations and diabetic morbidity. In effect, the ShearSole TM, should become the insole of choice for diabetic patients.