Shear & Pressure Reducing Insoles for the Diabetic Foot

剪切

• 批准号: 6616744
• 负责人: KEVIN R HIGGINS
• 金额: $ 32.58万
• 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 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6616744
• 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）：我们将评估该项目的可行性 ShearSoleTM 新颖的鞋垫可减少足部的压力和剪切力。不 市售鞋垫旨在减少剪切力。虽然有保险 医疗服务提供者在糖尿病患者身上花费了数百万美元？治疗鞋垫，没有 有关剪切或压力降低的科学数据。我们将评估最佳 第一阶段的粘合材料与使用相同材料的 ShearSole TM 设计进行比较 粘弹性材料的组合。我们将评估 2 个患者组，每组 150 人 为期 18 个月的试验中每组患者（总共 300 名）。对照组患者 手臂将穿着传统的粘合鞋垫，而第二只手臂将穿着传统的粘合鞋垫 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， 剪切力和材料特性会随着磨损而变化。本期二期 十八 (18) 个月的临床试验将评估其有效性 ShearSoleTM 降低糖尿病溃疡的发生率。整体研究 假设 ShearSole TM 将显着减少剪切力 与传统鞋垫相比，在不牺牲压力降低的情况下 特性或耐久性。从长远来看，这项技术将 纳入可移动的石膏助行器（以治愈溃疡）、轮椅垫中 和床垫（以防止褥疮的发展）。 拟议的商业应用：ShearSole TM 剪切和压力缓解鞋垫成本低廉，有望通过在鞋子中加热新型鞋垫的简单过程，彻底改变糖尿病患者的护理。 新颖的鞋垫包装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、截肢和糖尿病的发病率。 事实上，ShearSole TM 应该成为糖尿病患者的首选鞋垫。

项目成果

Wear and biomechanical characteristics of a novel shear-reducing insole with implications for high-risk persons with diabetes.

新型减剪鞋垫的磨损和生物力学特征对糖尿病高危人群的影响。

• DOI: 10.1089/dia.2005.7.638
• 发表时间: 2005
• 期刊: Diabetes technology & therapeutics.
• 作者: Lavery,LawrenceA;Lanctot,DanR;Constantinides,George;Zamorano,RubenG;Athanasiou,KyriacosA;Agrawal,CMauli
• 通讯作者: Agrawal,CMauli