CAD-CAM Technology for Diabetic Footwear

描述（由申请人提供）：糖尿病仍然是导致非创伤性下肢截肢的主要原因。大多数截肢之前都有足部溃疡，因此成功治疗或更好地预防足部溃疡应该会减少与糖尿病相关的截肢数量。大多数糖尿病患者的足部溃疡是继发于神经病变的保护性感觉丧失（LOPS）的结果，导致未察觉的损伤。由于神经病变目前无法逆转，因此保护LOPS足部免受伤害是次佳策略，鞋类一直被认为是预防原发性和继发性足溃疡的最重要方法。毫不奇怪，大多数神经性溃疡都发生在足底，发生在足底负荷高的地方，因此，重新分配负荷从而减轻压力的鞋垫应该可以减少足底溃疡的发生率，从而减少截肢的风险。然而，该领域的一个问题是，没有开发和验证明确的算法来可靠和可重复地设计和制造鞋垫，以卸载足底表面的高负荷部位。在第一和第二阶段的SBIR资金（R44 DK59074）下，DIApedia LLC现在已经完成了TrueContour鞋垫的开发，实现了这一目标，并且首次将脚的形状和行走的足底压力模式结合到设计规则中。在最近的一项临床试验中，TrueContour”鞋垫与之前仅基于形状的行业标准鞋垫相比，可预测地减少前足部位的足底压力21- 36%，力-时间积分40%和34% （P均< 0.0001）。TrueContour的鞋垫通常也优于由临床专家反复生产的高度定制的鞋垫。在这项拟议的随机对照盲法临床试验中，我们现在将测试TrueContour“鞋垫在预防先前和现在愈合的足底神经性足溃疡患者的足溃疡复发方面的临床疗效。这将是一项为期三年的多中心试验，滚动入组，每位患者随访15个月。据文献报道，有足底溃疡病史的患者在一年内复发率为10-60%。286例LOPS和足底溃疡在过去三个月内愈合的患者将被随机分配使用TrueContour“鞋垫或当前标准护理鞋垫。两周后，将测量鞋内足底压力，以记录TrueContour鞋垫增强的卸载效果。在15个月的时间里，鞋子的使用情况将由一种新型的安装在鞋子上的步长传感器监测。所有鞋垫将由中央制造设施提供，不需要标识。终点将由溃疡裁决小组根据照片进行评估，该小组对治疗任务不知情。这项研究将阐明，鞋子是否能够可靠地降低先前溃疡部位的足底压力，也能降低溃疡复发的风险。此外，一个积极的结果将进一步推动我们的努力，把这种产品推向更广阔的市场。它还将提供向CMS申请新代码所需的信息，用于新一代定量设计的治疗鞋垫。公共卫生相关性。在美国，大多数非意外造成的截肢都是由糖尿病造成的。大多数截肢手术都是从患者感觉不到的足部溃疡开始的，因为一些人的糖尿病会导致神经损伤。合适的鞋垫垫足底的鞋子应该保护糖尿病患者的神经损伤，防止溃疡和截肢。虽然许多鞋子和鞋垫都是为了这个目的而出售的，但直到现在还没有关于如何制作鞋垫的精确规则。DIApedia LLC首次根据患者的脚型和个人脚部的压力模式制定了这样的规则。我们现在提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溃疡。如果成功，这条研究路线将减少因糖尿病而截肢的人数。

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.