DIABETIC FOOT ULCER DEVICE

糖尿病足溃疡装置

• 批准号: 2791575
• 负责人: PAUL P BUREK
• 金额: $ 33.77万
• 依托单位: ROSE BIOMEDICAL DEVELOPMENT CORPORATION
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2001-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2791575
• 关键词: assistive device /technology; bioengineering /biomedical engineering; biomedical equipment development; clinical biomedical equipment; clinical research; decubitus ulcer; diabetes mellitus; foot; gait; human subject; medical complication; orthopedics; wound healing

Diabetic foot ulcers account for 55,000 amputations per year and are the leading cause of diabetic patient hospitalizations. Treat requires off- weighting of the foot through bed rest, wheelchair, crutches, healing sandals, modifier shoes, and/or bandaging treatments. Treatment compliance, how4ver, is difficult to maintain since diabetics with peripheral neuropathy does not feel pain in the affected limbs. Total contact casts (TCC) off-weight the wound while allowing for ambulation and healing without strict patient compliance. TCC's facilitate healing in up to 90% of cases. Unfortunately, only a small percentage of patients receive this treatment because it requires a extensive training, time consuming two person applications, and frequent follow-up recasting. In other words, TCCs are clinically-effective, but not cost-effective. RBDC proposes to develop the Fast Cast (FC)- a reusable, easy-to-apply, adjust and remove, ulcer healing system with the efficacy of TCC's. The FC will provide maximum off-weighting by shifting pressure from foot to lower leg. It will be easily adjusted as leg diameters change due to decreased edema and atrophy. The FC's ease of use should increase ut8iliztion rates, resulting in better diabetic foot ulcer treatment for more patients, lower related health care costs, fewer amputations and higher quality of life for diabetic patients. PROPOSED COMMERCIAL APPLICATION: Of the 14 million diagnosed diabetics in the U.S., 15%, or approximately 2.1 million patients suffer from foot ulcers. Each year 55,000 of these ulcers lead to amputations. If the proposed Fast Cast proves efficacious, this new device will join the substantial market of foot ulcer treatment devices. Further, the Fast Cast's low cost and ease of application and adjustment will allow it to significantly penetrate this market.

糖尿病足溃疡每年导致 55,000 例截肢，是糖尿病患者住院的主要原因。治疗需要通过卧床休息、轮椅、拐杖、愈合凉鞋、改良鞋和/或绷带治疗来减轻足部重量。然而，治疗依从性很难维持，因为患有周围神经病变的糖尿病患者不会感到受影响的四肢疼痛。全接触石膏 (TCC) 减轻了伤口的重量，同时允许移动和愈合，无需患者严格依从。 TCC 有助于高达 90% 的病例愈合。不幸的是，只有一小部分患者接受这种治疗，因为它需要大量的培训、耗时的两人应用以及频繁的后续重铸。换句话说，TCC 在临床上有效，但成本效益不高。 RBDC 提议开发 Fast Cast (FC)——一种可重复使用、易于应用、调整和移除的溃疡愈合系统，具有 TCC 的功效。 FC 将通过将压力从脚转移到小腿来提供最大程度的减重。由于水肿和萎缩减少，腿部直径发生变化，因此可以轻松调整。 FC 的易用性应该会提高使用率，从而为更多患者提供更好的糖尿病足溃疡治疗，降低相关医疗费用，减少截肢次数并提高糖尿病患者的生活质量。拟议的商业应用：在美国 1400 万确诊糖尿病患者中，15%（即大约 210 万）患者患有足部溃疡。每年有 55,000 个溃疡导致截肢。如果所提出的 Fast Cast 被证明是有效的，这种新设备将加入足部溃疡治疗设备的庞大市场。此外，Fast Cast 的低成本以及易于应用和调整的特点将使其能够显着渗透该市场。