Cast walker to Expedite Healing of Diabetic Foot Ulcer

描述(由投保人提供)：保险提供者花费数百万美元用于糖尿病相关伤口护理的假肢和降压方式；然而，没有关于剪切(摩擦)的科学数据，也没有关于降压的数据。目前，还没有商业上可用的可拆卸石膏行走装置来降低剪切。Salix Medical的(正在申请专利的)可拆卸石膏步行器(ACE Walker)使用独特的剪切调制技术，消除了脚底压力和剪切的峰值。这样的峰值通常会启动或加剧一种破坏性的途径，包括溃疡，并很可能导致糖尿病患者的截肢。这项随机临床试验将评估1)ACE步行器与2)临床黄金标准“全接触铸型”和3)标准愈合凉鞋治疗糖尿病足部溃疡的疗效。此外，这项研究还将评估各治疗组的功能状况和医疗费用。三组35名患有神经性溃疡的糖尿病患者将被选参加为期12周的临床试验。在基线和每隔两周进行一次临床评估，以评估伤口的大小和深度。

DESCRIPTION (provided by applicant): Insurance providers spend millions of dollars on prosthetics and pressure reducing modalities for diabetes-related wound care; however, no scientific data exists on shear (friction) and scarce data on pressure reduction. Presently, no commercially available removable cast walker reduces shear. Salix Medical's (patent pending) removable cast walker (ACE walker) uses a unique shear modulation technology to eliminate peaks in pressure and shear at the sole of the foot. Such peaks usually initiate or exacerbate a destructive pathway that involves ulceration and may well lead to amputation in patients with diabetes. This randomized clinical trial will evaluate the 1) ACE walker versus 2) the clinical 'gold standard" Total Contact Casts and 3) standard Healing Sandals to heal diabetic foot ulcers. In addition the study will evaluate functional status and health care costs among treatment groups. Three groups of thirty-five diabetics with neuropathic ulcerations will be selected to participate in a 12-week clinical trial. At baseline, and at two week intervals, clinical evaluations will be performed to assess wound size and depth.