Cast walker to Expedite Healing of Diabetic Foot Ulcer

演员步行者加速糖尿病足溃疡的愈合

• 批准号: 6668664
• 负责人: KEVIN R HIGGINS
• 金额: $ 35.03万
• 依托单位: DIABETICA SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6668664
• 关键词: assistive device /technology; biomechanics; biomedical equipment development; clinical research; decubitus ulcer; diabetes mellitus; diabetic neuropathy; evaluation /testing; foot; gait; human subject; mechanical stress; medical complication; orthopedics; orthotics; patient oriented research; wound healing

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.

描述（由申请人提供）：保险提供商花费数百万美元用于糖尿病相关伤口护理的假体和减压方式;然而，没有关于剪切（摩擦）的科学数据，也缺乏关于减压的数据。目前，还没有商业上可获得的可移除的铸件步行者减小剪切。Salix Medical的（正在申请专利的）可移动石膏步行者（ACE步行者）使用独特的剪切调制技术来消除足底的压力和剪切峰值。这些峰值通常会引发或加剧破坏性途径，包括溃疡，并可能导致糖尿病患者截肢。本随机临床试验将评价1）ACE步行者与2）临床“金标准”全接触石膏型和3）标准愈合凉鞋治疗糖尿病足溃疡的效果。此外，该研究还将评估治疗组之间的功能状态和医疗保健费用。将选择三组35名患有神经性溃疡的糖尿病患者参加为期12周的临床试验。在基线时，每隔两周进行一次临床评价，以评估伤口尺寸和深度。