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: 7065182
• 负责人: JOSEPH L LOOMIS
• 金额: $ 65.34万
• 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 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7065182
• 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，每年在糖尿病患者中进行80,000多次下肢截肢。脚溃疡更为普遍，大多数截肢的路径始于溃疡。这些问题的医疗保健费用估计为每年近110亿美元。溃疡保持开放的时间越长，感染并导致截肢的可能性就越大。 “通常的护理”通常仅在20周内治愈约30％的溃疡，但是总的接触式铸件（TCC）平均可以在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下伤口，并且由于患者无法将其删除，因此无需患者遵守情况。尽管在疗效方面比“通常的护理”具有重要优势，但提供者对TCC的接受却很差，因此必须找到有效的替代方案。在完整的I期SBIR下，我们已经证明了原型负荷敷料（LRD）的可行性，该原型也不需要完全遵守患者。我们已经开发了第二代原型，这些原型显示出与TCC相当的卸载原型，并且我们已经开始对实际患者进行测试。我们还正在与一家主要的敷料制造商进行谈判，这可能会导致最终产品的许可。在此II阶段建议下，我们将完善LRD的设计，以促进其在伤口部位的应用，同时保持最佳的卸载并确保患者遵守情况。此外，我们将对LRD检验进行随机对照试验，该试验假设LRD在临床结局方面与TCC在治疗神经性步道溃疡患者时将是等效的。该产品不仅具有商业潜力，而且还提供了将工具放在提供商手中的可能性，这些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。