OPTIMAL OFF-LOADING THERAPY FOR HEALING DIABETIC ULCERS

治疗糖尿病溃疡的最佳减负疗法

• 批准号: 6517863
• 负责人: DAVID Russell SINACORE
• 金额: $ 18.18万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-01 至 2005-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6517863
• 关键词: assistive device /technology; clinical trials; diabetic neuropathy; foot; health care cost /financing; human subject; human therapy evaluation; longitudinal human study; patient oriented research; skin ulcer; wound healing

DESCRIPTION (adapted from the application) Foot ulcers in people with diabetes mellitus represent a major public health problem of increasing magnitude and escalating health care expenditure. Diabetic foot ulcers are frequently due to a combination of peripheral neuropathy, minor trauma, peripheral vascular disease and accompanying foot deformity which often lead directly to lower extremity amputation (LEA) Currently, total contact casting (TCC) is the most rapid and effective method for healing diabetic neuropathic foot ulcers. TCC has several major drawbacks including requiring specialized skills in the application, patient reports of difficulties with walking and ADL function and frequent cast changes to prevent complications. These limitations have prevented its wide-spread adoption as the optimal off-loading therapy. Recently, some removable ankle foot orthoses (AFOs) have been shown to reduce plantar pressures to a similar extent as TCC, though ulcer healing outcomes have not yet been demonstrated. Removable AFOs offer many potential advantages over TCC such as lower costs, easier patient application and greater convenience by requiring fewer visits to health care specialists. The overall goal of this application is to conduct a prospective, randomized controlled clinical trial comparing TCC to a removable AFO to determine the optimal off-loading therapy for healing diabetic, neuropathic foot ulcers. The Specific Aims of this project are to determine the percent of subjects with Wagner grade 1 or 2 neuropathic foot ulcers who completely heal within 8 weeks; and the time (in days) it requires to achieve complete healing using each off-loading therapy. Additional aims will be to determine the impact each off-loading therapy has on subjects' level of impairment, functional limitation, disability and to determine the costs and cost-effectiveness associated with each offloading therapy based on discrete indicators of patient severity and compliance to each therapy. The results of this application will have an immediate impact toward increasing our current understanding of the magnitude of pressure offloading which is required to achieve successful healing outcomes. In addition, we will define the optimal off-loading therapy for rapid and effective ulcer healing outcomes which promise to reduce the annual number of LEAs, limit the burden of disability and demonstrate the most cost-effective pressure off-loading therapy in patients with diabetes mellitus and chronic foot ulcers.

描述（改编自应用程序） 糖尿病患者的足部溃疡是一个主要的公共卫生问题 日益严重的问题和不断上升的医疗保健支出。 糖尿病足溃疡通常是由于周围的组合， 神经病变、轻微创伤、周围血管疾病和伴随的足部 经常直接导致下肢截肢（莱亚）的畸形 目前，全接触铸造（TCC）是最快速、最有效的方法 用于治疗糖尿病神经性足部溃疡。TCC有几个主要缺点 包括要求应用中的专业技能、患者报告 行走和ADL功能困难以及频繁更换石膏，以防止 并发症这些限制阻止了它作为 最佳卸载治疗。最近，一些可拆卸的踝足矫形器 （AFO）已经显示出将足底压力降低到与TCC相似的程度， 尽管溃疡愈合结果尚未得到证实。AFOs 与TCC相比，具有许多潜在优势，例如成本更低，患者更容易接受 应用和更大的便利性，减少了医疗保健的访问 专家。本申请的总体目标是进行前瞻性的， 比较TCC与可拆卸AFO的随机对照临床试验， 确定治疗糖尿病、神经病、 足部溃疡该项目的具体目标是确定 完全愈合的瓦格纳1级或2级神经性足溃疡受试者 8周内;以及达到完全愈合所需的时间（天） 使用每一个卸载疗法。其他目标将是确定 每种卸载疗法对受试者的损伤水平、功能 限制，残疾和确定成本和成本效益 基于患者的离散指标与每个卸载治疗相关联 严重程度和对每种治疗的依从性。本申请的结果将 对增加我们目前对生物多样性的理解有直接的影响。 成功实现所需的压力卸载量 治愈的结果。此外，我们将确定最佳的卸载治疗 快速和有效的溃疡愈合的结果，承诺减少 每年的执法机构数量，限制残疾的负担， 糖尿病患者的经济有效的压力减轻治疗 和慢性足部溃疡