Comparative Effectiveness of Adjunctive Devices For the Previous

描述（申请人提供）：下肢截肢（LEA）是糖尿病的一种非常严重和灾难性的并发症。根据2005年疾病控制中心的数据，每次出院时，糖尿病患者的LEA总发生率为每1,000名糖尿病患者4.3例，而其余人口每年约为每10,000名糖尿病患者3例。每年超过50%的非创伤性截肢发生在糖尿病患者身上，从而使糖尿病成为导致下肢非创伤性截肢的主要原因。由于足部溃疡通常是导致足部溃疡的最重要原因，因此对足部溃疡的有效治疗对于预防足部溃疡至关重要。据估计，2004年用于治疗伤口的直接医疗费用为97亿美元。现在的护理可以包括使用辅助治疗标准治疗称为高压氧。2005年，在一个关于伤口护理的医疗保险覆盖咨询会议上，有人指出，评估佐剂疗效的大型随机临床试验进行的可能性被认为非常值得怀疑。不幸的是，还没有进行大规模的队列研究来确定这种装置的有效性。这项应用的最终目的是为了更好地理解高压氧治疗的相对有效性，我们之前使用社区伤口护理中心的医疗记录/管理数据研究了下肢慢性伤口。我们计划使用工具变量方法、有效和成本效益的研究设计和国家愈合公司（美国最大的伤口社区伤口管理公司之一）的数据库来调查这个问题。

DESCRIPTION (provided by applicant): Lower extremity amputation (LEA) is a very severe and catastrophic complication of diabetes mellitus. According to the Centers for Disease Control in 2005, per hospital discharge the overall rate of LEA is 4.3 per 1,000 persons with diabetes as compared to about 3 per 10,000 per year the rest of our population. Annually more than 50% of all non-traumatic amputations occur in patients with diabetes, thereby making diabetes the leading cause of lower extremity non-traumatic amputation. Because a foot ulcer is often the single most important reason that an individual eventually has an LEA, effective treatment for foot ulcer is essential for the prevention of LEA. It was estimated in 2004 that $9.7 billion dollars in direct medical costs were allocated to the treatment of wounds. Care now can include the use of treatment adjuvant to standard therapy called hyperbaric oxygen. In 2005, at a Medicare Coverage Advisory meeting on wound care, it was noted that the likelihood that large randomized clinical trials evaluating the efficacy of adjuvant agents would be conducted was deemed very doubtful. Unfortunately, large cohort studies have also not been conducted to determine the effectiveness of this device. The ultimate goals of this application are to better understand the comparative effectiveness of hyperbaric oxygen therapy when we have previously studied chronic wounds of the lower extremity using medical records/administrative data from community-based wound care centers. We plan to investigate this issue using an instrumental variable approach, effective and cost-effectiveness study designs, and database from National Healing Corporation, which is one of the largest wound community-based wound management companies in the United States. PUBLIC HEALTH RELEVANCE: In the US, nearly 80,000 Lower extremity amputations are preformed on diabetics each year. A cost estimate in 2004 revealed the total direct expenditures for the treatment of all chronic wounds in the US totaled $9.7 billion dollars. The ultimate goals of this application are to better understand the comparative and cost effectiveness of hyperbaric oxygen therapy, an adjuvant device therapy used to treat foot ulcer on those with diabetes, and how this treatment impacts and prevents lower extremity amputation.