Shear & Pressure Reducing Insoles for the Diabetic Foot

剪切

• 批准号: 6442607
• 负责人: KEVIN R HIGGINS
• 金额: $ 42.78万
• 依托单位: DIABETICA SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-07-15 至 2004-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6442607
• 关键词: assistive device /technology; biomechanics; clinical research; clinical trials; consumer product; decubitus ulcer; diabetes mellitus; diabetes mellitus therapy; disease /disorder prevention /control; elasticity; foot; gait; human subject; mechanical stress; patient oriented research; technology /technique development

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.

描述（由申请人提供）：我们将评估的可行性， ShearSoleTM新型鞋垫，以减少压力和脚上的剪切力。没有 商业上可获得的鞋垫被设计成减少剪切。虽然保险 提供者在糖尿病患者身上花费数百万？治疗鞋垫，没有 关于剪切或减压的科学数据。我们将评估最佳的 第一阶段的粘结材料与ShearSole TM设计相比， 粘弹性材料的组合。我们将评估2组患者，每组150人 在18个月的试验中，每组300例患者。对照组患者 一只手臂将穿着传统的粘合鞋垫，而另一只手臂将 收到ShearSoleTM。在基线和18个月试验结束时， 鞋内步态实验室和体外生物力学参数将测量压力， 剪切和材料特性，因为这些特性随磨损而变化。这项II期 为期18个月的临床试验将评估 减少糖尿病溃疡的发病率。总体研究 假设ShearSole TM将提供显着的剪切减少， 与传统鞋垫相比，不牺牲压力降低 特性或耐用性。从长远来看，这项技术将 纳入可拆卸石膏助行器（用于治疗溃疡）、轮椅垫 和床垫（防止褥疮溃疡的发展）。 拟定商业应用：低成本的ShearSole TM剪切和压力缓解鞋垫承诺革命性的糖尿病患者护理通过一个简单的程序weating新鞋垫在他们的鞋。 在一种新颖的鞋内底包装中提供了剪切和压力释放特性。 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，ShearSole TM应该成为糖尿病患者的首选鞋垫。