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性下肢截肢的主要原因。大多数截肢手术之前都有足部溃疡，因此成功治疗或更好地预防足部溃疡应该减少糖尿病相关截肢的数量。糖尿病患者的大多数足部溃疡是继发于神经病变的保护性感觉丧失（LOPS）的结果，该神经病变允许未察觉的损伤。由于神经病变目前无法逆转，因此用LOPS保护足部免受损伤是下一个最佳策略，鞋类长期以来一直被认为是预防原发性和继发性足部溃疡的最重要方法。毫不奇怪，大多数神经性溃疡是足底的，发生在高足底负荷点，因此，重新分配负荷并因此减少压力的鞋垫应降低足底溃疡率，从而降低截肢风险。然而，该领域中的问题是，尚未开发和验证用于可靠且可重复地设计和制造减轻足底表面上的高负荷部位的鞋垫的清晰算法。在第一和第二阶段SBIR资金（R44 DK 59074）DIApedia有限责任公司现在已经完成了TrueContour”鞋垫的开发，实现了这一目标，并首次将脚的形状以及步行足底压力模式纳入设计规则。在最近的一项临床试验中，与仅基于形状的现有行业标准鞋垫相比，TrueContour”鞋垫已被证明可预测地将前足部位的足底压力降低21- 36%，力-时间积分降低40%和34%（均P < 0.0001）。TrueContour”鞋垫也往往优于由专家临床医生生产的迭代生产的高度定制的鞋垫。在这项随机对照盲法临床试验中，我们现在将测试TrueContour鞋垫在预防足部溃疡复发方面的临床疗效，这些患者以前患有足底神经性足部溃疡，现在已经愈合。这将是一项为期三年的多中心试验，每例患者将进行滚动招募和15个月的随访。文献中报告了既往有足底溃疡的患者第一年内的复发率为10-60%。286名LOPS和足底溃疡在过去三个月内愈合的患者将随机接受TrueContour鞋垫或当前标准护理鞋垫。鞋内足底压力将在两周的“突破”后测量，以记录TrueContour”鞋垫增强的卸载功效。在15个月的时间内，鞋子的使用将由一种新型的鞋安装步骤传感器监测。患者将对病情设盲 所有鞋垫将由中央制造厂供应，不带标识。将由对治疗分配设盲的溃疡裁定小组根据照片评估终点。这项研究将阐明是否鞋可靠地降低足底压力在网站上先前溃疡也降低溃疡复发的风险。此外，积极的结果将进一步推动我们将该产品推向更广泛市场的努力。它还将提供所需的信息，以申请CMS为这一新一代定量设计的治疗鞋垫的新代码。公共卫生相关性。 糖尿病是导致美国大部分截肢的原因，而这些截肢不是由事故引起的。大多数这样的截肢开始于一个人感觉不到的足部溃疡，因为有些人可能会因糖尿病而发生神经损伤。合脚的鞋，鞋垫垫在脚底，应该保护神经损伤的糖尿病患者，防止溃疡和截肢。虽然许多鞋子和鞋垫都是为此目的而出售的，但直到现在还没有关于如何制作这种鞋垫的确切规则。DIApedia有限责任公司首次根据患者的脚形和个人脚底的压力模式制定了这样的规则。我们现在建议测试这些高度定制的鞋垫是否可以预防至少有一个先前溃疡已经治疗和愈合的患者的足部溃疡。如果成功的话，这一系列的研究应该会减少糖尿病截肢的数量。