CAD-CAM Technology for Diabetic Footwear

糖尿病鞋的 CAD-CAM 技术

• 批准号: 7693752
• 负责人: JOSEPH L LOOMIS
• 金额: $ 87.54万
• 依托单位: DIAPEDIA, LLC
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-15 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7693752
• 关键词: Accidents; Adoption; Affect; Algorithms; Amputation; Arts; Attention; Blinded; Blindness; CAD-CAM; Categories; Characteristics; Clinical Trials; Code; Complications of Diabetes Mellitus; Cross-Sectional Studies; Custom; Deformity; Development; Diabetes Mellitus; Dorsal; End stage renal failure; Enrollment; Esthesia; Foot Ulcer; Funding; Future; Generations; Goals; Guide prevention; Healed; Health; Healthcare Common Procedure Coding System; Individual; Industry; Injury; Intervention; Link; Literature; Living Wills; Lower Extremity; Marketing; Measures; Medicare; Monitor; Nerve; Neuropathy; Outcome; Patients; Pattern; Persons; Phase; Plantar Ulcers; Prevention; Prevention strategy; Published Comment; Quality of life; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recurrence; Reporting; Research; Risk; Secondary to; Shapes; Shoes; Site; Skin; Skin Ulcer; Small Business Innovation Research Grant; Surface; Technology; Testing; Therapeutic; Time; TimeLine; Ulcer; Walking; Work; adjudication; attenuation; authority; base; clinical efficacy; clinically relevant; design; diabetic; diabetic patient; experience; follow-up; foot; healing; novel; orthotics; pressure; prevent; public health relevance; research and development; sensor; standard of care

DESCRIPTION (provided by applicant): Diabetes remains the leading cause of non-traumatic lower extremity amputations. Most amputations are preceded by a foot ulcer, so that successfully treating, or better still preventing, foot ulcers should reduce the number of diabetes related amputations. The majority of foot ulcers in diabetic patients are the result of loss of protective sensation (LOPS) secondary to neuropathy that permits unperceived injury. Since neuropathy cannot presently be reversed, protecting the foot with LOPS from injury is the next best strategy, and footwear has long been considered to be the most important approach to primary and secondary foot ulcer prevention. Not surprisingly most neuropathic ulcers are plantar, occurring at points of high plantar loading, so that insoles that redistribute load and therefore reduce pressure should reduce plantar ulcer rates and therefore amputation risk. However, a problem in this field had been that clear algorithms to reliably and reproducibly design and manufacture insoles that off-load highly loaded sites on the plantar surface had not been developed and validated. Under the Phase I & II SBIR funding (R44 DK59074) DIApedia LLC has now completed the development of the TrueContour" insole that accomplishes this goal and, for the first time, incorporates both the shape of the foot as well as the walking plantar pressure pattern into the design rules. In a recent clinical trial, TrueContour" insoles have been shown to predictably reduce plantar pressure at forefoot sites by 21- 36% and force-time integral by 40% and 34% (both P < 0.0001) compared to prior industry standard insoles based on shape only. TrueContour" insoles are also often better than iteratively produced highly customized insoles produced by expert clinicians. In this proposed randomized controlled blinded clinical trial we will now test the clinical efficacy of TrueContour" insoles in preventing foot ulcer recurrence in patients with previous and now healed plantar neuropathic foot ulcers. This will be a three-year multi-center trial with rolling enrolment and 15 months of follow up for each patient. Recurrence rates of 10-60% within the first year have been reported in the literature for patients with a prior plantar ulcer. 286 patients with LOPS and a plantar ulcer healed within the last three months will be randomized to receive TrueContour" insoles or current standard of care insoles. In-shoe plantar pressure will be measured after a two-week `break in' to document the enhanced off-loading efficacy of the TrueContour" insoles. Shoe use during the 15 month period will be monitored by a novel shoe-mounted step sensor. Patients will be blinded to condition all insoles will be supplied from central fabrication facilities without identification. End-points will be assessed from photographs by an Ulcer Adjudication Panel blinded to the treatment assignment. This study will clarify whether or not footwear that reliably reduces plantar pressure at sites of prior ulceration also reduces the risk for ulcer recurrence. In addition, a positive result will further our effort to bring this product to a wider market. It will also provide the information needed to petition CMS for new codes for this new generation of quantitatively designed therapeutic insoles. PUBLIC HEALTH RELEVANCE. Diabetes is responsible for most of the amputations in the US that are not caused by accidents. Most such amputations start with a foot ulcer that the person cannot feel, because of nerve damage that can develop due to diabetes in some people. Well fitting shoes with insoles that cushion the bottom of feet should protect diabetic patients with nerve damage, and prevent ulcers and amputations. While many shoes and insoles are sold for this purpose, there have not until now been precise rules for how such insoles should be made. DIApedia LLC has for the first time developed such rules, based on the patient's foot shape and for the first time also on the pressure pattern under an individual's foot. We are now proposing to test whether these highly customized insoles can prevent foot ulcers in patients who have had at least one prior ulcer that has been treated and healed. If successful, this line of research should reduce the number of amputations due to diabetes.

描述（由申请人提供）：糖尿病仍然是非创伤下肢截肢的主要原因。大多数截肢之前是脚溃疡，因此成功治疗或更好地预防脚步溃疡应减少糖尿病相关截肢的数量。糖尿病患者中的大多数足球溃疡是由于神经病继发于允许损伤的神经病变的丧失（LOPS）的结果。由于目前无法逆转神经病变，因此在受伤的情况下保护脚是下一个最佳策略，长期以来，鞋类被认为是预防初级和次要足溃疡的最重要方法。毫不奇怪，大多数神经性溃疡都是足底的，发生在高足底负荷的位置，因此重新分配负荷并降低压力的鞋垫应降低足底溃疡率，从而降低了截肢风险。但是，该领域的一个问题是清晰的算法可以可靠，可重复地设计和制造鞋垫，即未开发和验证足底表面上的高负载位点。在第I阶段和II阶段SBIR资金（R44 DK59074）下，Diapedia LLC现在已经完成了TrueContour的开发。与以前的行业标准鞋垫相比，力度时间积分占40％和34％（均为p <0.0001）。 truecontour“鞋垫通常也比迭代性生产的专家临床医生生产的高度定制的鞋垫要好。在这项拟议的随机对照盲目临床试验中，我们现在将测试Truecontour的临床疗效“鞋垫在防止先前和现在愈合的植物性神经病变卵子的患者的足部溃疡复发中的鞋垫。这将是一项为期三年的多中心试验，每位患者的入学率和15个月的随访。对于先前的足底溃疡患者，文献中已经报道了第一年的复发率为10-60％。 286例在过去三个月内愈合的患者和底溃疡患者将被随机接收TrueContour“鞋垫或当前的护理标准鞋垫。在为期两周的“中断”后，将测量脚下的足底压力，以记录增强的Truecontour“ Insoles” Insoles的增强功效。 15个月内的鞋子使用将通过一种新颖的鞋子台阶传感器来监视。患者将视而不见所有鞋垫的病情，而没有鉴定。终点将通过对治疗分配的溃疡裁决面板从照片中进行评估。这项研究将阐明在先前溃疡部位可靠地降低足底压力的鞋类是否也降低了溃疡复发的风险。此外，积极的结果将进一步努力将该产品带入更广泛的市场。它还将为新一代定量设计的治疗鞋垫提供请求CMS的新代码所需的信息。公共卫生相关性。 糖尿病负责美国的大多数截肢，这不是由事故引起的。大多数这样的截肢始于该人无法感觉到的脚溃疡，因为某些人会因糖尿病而产生的神经损伤。适合鞋垫的良好鞋，可缓冲脚的底部，应保护神经损伤的糖尿病患者，并防止溃疡和截肢。尽管为此目的出售了许多鞋子和鞋垫，但到目前为止，还没有关于如何制作此类鞋垫的精确规则。 Diadpedia LLC首次根据患者的脚形制定了这样的规则，也是第一次在个人脚下的压力模式上制定了这种规则。现在，我们建议测试这些高度定制的鞋垫是否可以防止至少有一种已接受治疗和治愈的溃疡的患者的足球溃疡。如果成功，这一研究应减少由于糖尿病引起的截肢数量。