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OPTIMAL OFF-LOADING THERAPY FOR HEALING DIABETIC ULCERS

治疗糖尿病溃疡的最佳减负疗法

基本信息

批准号：
6729068
负责人：
DAVID Russell SINACORE
金额：
$ 23.35万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-04-01 至 2007-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6729068
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

项目摘要

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.

说明(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健康问题医疗保健支出规模不断扩大和不断攀升的问题。糖尿病足部溃疡通常是由于外周联合神经病、轻微创伤、周围血管疾病和伴足通常直接导致下肢截肢(LEA)的畸形目前，全接触铸造(Tcc)是最快速有效的方法。用于治疗糖尿病神经性足部溃疡。TCC有几个主要缺点包括在应用程序中需要专业技能、患者报告行走和ADL功能困难，经常更换石膏以防止并发症。这些限制阻碍了它作为最佳减负疗法。最近，一些可拆卸的脚踝矫形器 (AFO)已被证明可以降低足底压力，其程度与TCC相似，尽管溃疡愈合的结果还没有得到证实。可拆卸AFO 提供许多与TCC相比的潜在优势，例如更低的成本、更容易的患者应用程序和更大的便利性，因为需要更少的医疗保健专家。这个应用的总体目标是进行前瞻性的， TCC与可拆卸AFO的随机对照临床试验确定治疗糖尿病和神经性病变的最佳减负疗法脚部溃疡。该项目的具体目标是确定 Wagner 1级或2级神经性足部溃疡完全愈合的受试者 8周内；以及实现完全愈合所需的时间(以天为单位) 使用每一种减负疗法。其他目标将是确定影响每种减负疗法都对受试者的损伤水平、功能限制、残疾，并确定费用和成本效益根据患者的不同指标与每种减负治疗相关联严重程度和对每种治疗的依从性。此应用程序的结果将对增加我们目前对成功实现压力卸载所需的压力大小治愈的结果。此外，我们还将定义最佳的减负治疗对于快速有效的溃疡愈合结果，这有望减少每年的LEA数量，限制残疾负担，并展示最多糖尿病患者的高性价比减压治疗和慢性足部溃疡。