CAD-CAM Technology for Diabetic Footwear

适用于糖尿病鞋类的 CAD-CAM 技术

• 批准号: 7932393
• 负责人: JOSEPH L LOOMIS
• 金额: $ 22.45万
• 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/7932393
• 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(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，所以成功地治疗或更好地预防足部溃疡应该会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(LOP)丧失的结果，这种损害允许不知不觉的伤害。由于神经病变目前还不能逆转，保护脚部免受损伤是下一个最好的策略，而鞋类一直被认为是预防原发和继发性足部溃疡的最重要的方法。不足为奇的是，大多数神经性溃疡都发生在足底，发生在足底负荷较高的位置，因此，重新分配负荷从而降低压力的鞋垫应该会降低足底溃疡的发生率，从而降低截肢风险。然而，这一领域的一个问题是，还没有开发和验证可靠和可重复地设计和制造鞋垫的明确算法，这些鞋垫可以卸载足底表面的高负荷部位。根据第一阶段和第二阶段的SBIR资助(R44 DK59074)，DIApedia LLC现在已经完成了TrueConour“鞋垫的开发，从而实现了这一目标，并首次将脚的形状以及行走的足底压力模式纳入了设计规则。在最近的临床试验中，TrueConour”鞋垫被证明与仅基于形状的先前行业标准鞋垫相比，可以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%(P&lt；0.0001)。在这项拟议的随机对照临床试验中，我们现在将测试TrueConour“鞋垫”在预防足底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，每个患者滚动登记和15个月的随访。有文献报道，有足底溃疡病史的患者在第一年内复发率为10-60%。286名在过去三个月内痊愈的大腿和足底溃疡患者将被随机分成两组，接受TrueConour“鞋垫”或目前标准护理鞋垫。在两周的“突破”后，将测量鞋底压力，以证明TrueConour“鞋垫的增强减负效果。在这15个月期间，鞋的使用情况将通过一种新型的鞋式步进传感器进行监测。患者将被蒙在鼓里，所有鞋垫将由中央制造设施供应，无需识别。终点将由一个对治疗任务视而不见的溃疡判定小组根据照片进行评估。这项研究将阐明，能够可靠地降低先前溃疡部位足底压力的鞋类是否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将该产品推向更广泛的市场。它还将提供所需的信息，以向CMS申请新一代定量设计的治疗性鞋垫的新代码。与公共卫生相关。在美国，大多数非意外造成的截肢都是由糖尿病造成的。大多数这样的截肢始于一个人感觉不到的足部溃疡，因为一些人可能会因为糖尿病而发展成神经损伤。合适的鞋垫可以缓冲脚底，保护患有神经损伤的糖尿病患者，并防止溃疡和截肢。虽然许多鞋子和鞋垫都是为了这个目的而出售，但到目前为止，还没有关于如何制作这样的鞋垫的确切规则。DIApedia LLC首次根据患者的足部形状和个人脚下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患者的足部溃疡，这些患者之前至少有一次溃疡经历过治疗和治愈。如果成功，这一系列研究应该会减少因糖尿病而截肢的数量。