Diabetic Foot Ulcer Healing by Load Relieving Dressings

通过减轻负荷敷料治愈糖尿病足溃疡

• 批准号: 6934961
• 负责人: JOSEPH L LOOMIS
• 金额: $ 49.27万
• 依托单位: DIAPEDIA, LLC
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6934961
• 关键词: assistive device /technology; biomedical equipment development; clinical research; clinical trials; diabetes mellitus; diabetic angiopathy; diabetic neuropathy; foot; human subject; human therapy evaluation; mechanical pressure; medical complication; patient oriented research; skin ulcer; surgery material /equipment; technology /technique development; therapy design /development; wound healing

DESCRIPTION (provided by applicant): In the US more than 80,000 lower extremity amputations are performed in diabetic patients per year. Foot ulcers are much more common and the path to most amputations starts with an ulcer. The health care cost of these problems has been estimated to be almost $11 billion per year. The longer an ulcer stays open, the more likely it is to get infected and lead to an amputation. "Usual care" heals typically only about 30% of ulcers in 20 weeks, yet a total contact cast (TCC) can heal > 90% of ulcers in an average of 8 weeks. The main advantage of the TCC over other approaches is that it mechanically off-loads the wound and, since it cannot be removed by the patient, does so without need for patient compliance. Despite its significant superiority over "usual care" in terms of efficacy, acceptance of the TCC by providers is poor and thus efficacious alternatives must be found. Under the completed phase I SBIR we have demonstrated feasibility of a prototype Load Relieving Dressing (LRD) that also does not demand complete patient compliance. We have developed second generation prototypes which show off-loading equivalent to that of a TCC and we have begun testing in actual patients. We are also negotiating an agreement with a major dressing manufacturer which could lead to licensing of the final product. Under this phase II proposal we will refine the design of the LRD to facilitate its application to the wound site while maintaining optimal off-loading and ensuring patient compliance. In addition we will perform a randomized controlled trial of the LRD testing the hypothesis that the LRD will be equivalent in terms of clinical outcomes to the TCC in the treatment of patients with neuropathic foot ulcers. This product not only has commercial potential, but also offers the possibility of putting a tool into the hands of providers which could heal many ulcers faster than is usual at present and could therefore prevent many lower extremity amputations.

描述（由申请人提供）：在美国，每年有超过80，000例糖尿病患者接受下肢截肢手术。足部溃疡更为常见，大多数截肢手术都是从溃疡开始的。据估计，这些问题的医疗费用每年约为110亿美元。溃疡开放的时间越长，就越有可能感染并导致截肢。“口腔护理”通常在20周内仅治愈约30%的溃疡，而全接触管型（TCC）可以在平均8周内治愈> 90%的溃疡。与其他方法相比，TCC的主要优点是它可以机械地卸载伤口，并且由于它不能由患者移除，因此无需患者依从性即可移除。尽管其显着的优越性，在疗效方面的“常规护理”，接受TCC的供应商是穷人，因此有效的替代品必须found.Under完成的第一阶段SBIR，我们已经证明了原型负荷减轻敷料（LRD），也不需要完全的患者依从性的可行性。我们已经开发了第二代原型，其显示出与TCC相当的卸载，并且我们已经开始在实际患者中进行测试。我们还正在与一家主要敷料制造商谈判一项协议，该协议可能导致最终产品的许可证。在本II期提案中，我们将改进LRD的设计，以便于其应用于伤口部位，同时保持最佳卸载并确保患者依从性。此外，我们将进行一项LRD随机对照试验，以检验LRD在治疗神经性足溃疡患者的临床结局方面与TCC等同的假设。该产品不仅具有商业潜力，而且还提供了将工具交到提供者手中的可能性，该工具可以比目前通常更快地治愈许多溃疡，因此可以防止许多下肢截肢。