Diabetic Foot Ulcer Healing by Load Relieving Dressings

描述（由申请人提供）：在美国，每年有超过80,000例糖尿病患者进行下肢截肢手术。足部溃疡更为常见，大多数截肢都是从溃疡开始的。据估计，这些问题造成的卫生保健费用每年将近110亿美元。溃疡裂开的时间越长，就越有可能感染并导致截肢。“常规护理”通常只能在20周内治愈30%的溃疡，而全接触石膏（TCC）平均在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减轻伤口的负荷，并且由于患者无法将其移除，因此无需患者的配合。尽管TCC在疗效方面明显优于“常规护理”，但提供者对TCC的接受程度较低，因此必须找到有效的替代方案。在完成的I期SBIR中，我们已经证明了一种原型负载缓解敷料（LRD）的可行性，该敷料也不需要患者完全依从性。我们已经开发了第二代原型，显示出与TCC相当的卸载，我们已经开始在实际患者中进行测试。我们还在与一家主要的敷料制造商谈判一项协议，这可能导致最终产品的许可。在这个第二阶段的建议中，我们将改进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和确保患者的依从性。此外，我们将对LRD进行一项随机对照试验，以验证LRD在治疗神经性足溃疡患者的临床结果方面与TCC相同的假设。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。

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.