Pressure Alternating Shoes for Prevention of Diabetic Foot Ulcers

摘要 糖尿病足部溃疡继续给美国医疗系统和患者带来负担，估计每年的成本为 300亿美元和10万的截肢率。然而，问题的确切原因仍有待解决。 众所周知，这是多因素的。糖尿病足病变有一种生物力学病理，涉及机械 压力作用于脚下；然而，足部压力本身并不能很好地预测溃疡，因为溃疡是 已知发生在不被认为有害的压力水平。关于病毒的病理影响的结果 足底剪切还没有定论。预防性鞋类，专为解决峰值压力而设计 在预防溃疡方面效果不佳，这进一步表明该病的病理是多因素的。一个 关于溃疡的另一种理论认为，糖尿病周围神经病变导致不同类型的 糖尿病患者的足底负荷，从而可能导致组织压痛和破裂。 研究表明，健康的人会根据感觉反馈改变负荷模式，这会阻止 区域范围内的组织压痛和疼痛。由于神经病变，糖尿病足的某些区域 被认为经历了反复的压力，但对不适或疼痛的反应不会得到缓解，这些 压力会造成。长时间重复可能会导致组织失效，即使在较低但未缓解的情况下， 机械应力。开发有效的鞋类和干预策略以预防糖尿病截肢 需要一种综合的方法来解决脚部溃疡的多种原因，并允许 用于研究这些未解除的重复应力。在这项研究中，我们将开发压力交流鞋 (PAS)，这将提供选择性的休息足底方面，以防止糖尿病溃疡。这个 这种鞋的最终目的将是限制局部足底应力的重复，特别是在峰值应力位置， 并为组织提供了恢复的机会。这种周期性的卸货也将有助于防止缺血 足底组织的状况，特别是长期站立的糖尿病患者。我们将设计和 测试PAS以实现选择性休息功能，并评估其安全性、可用性、生物力学性能 健康和糖尿病受试者的特征和舒适度。这将是第一次对一种 主动调节足底表面的机械负荷以防止足部溃疡的装置，将允许 系统研究周期性机械负荷对足部溃疡形成的影响，这将推动 对糖尿病足部护理领域的了解。归根结底，这样的研究有可能对 长期护理糖尿病足溃疡高发患者，提高其生活质量。

ABSTRACT Diabetic foot ulcers continue to burden the US healthcare system and patients with an estimated annual cost of $30 billion and amputation rates of 100,000. The exact etiology of the problem remains to be resolved, though it is known to be multi-factorial. Diabetic foot lesions have a biomechanical pathology that involves mechanical stresses acting under the foot; however, foot pressure alone is not a good predictor of ulcers, since ulcers are known to occur at pressure levels that are not considered harmful. Results regarding the pathological effects of plantar shear are not yet conclusive. Preventive footwear, designed to address only peak pressures have shown poor success in preventing ulceration, which further indicates that the pathology is multi-factorial. An alternative theory regarding ulceration states that diabetic peripheral neuropathy leads to unvarying patterns of plantar loading in diabetic patients, which may consequently result in tissue tenderness and breakdown. Healthy individuals have been shown to shift their loading patterns based on sensory feedback, which prevents tissue tenderness and pain at the regional scale. Due to neuropathy, certain regions of the diabetic foot are thought to experience repetitive stresses that are not relieved in response to discomfort or pain that these stresses would create. Prolonged repetition might result in failure of the tissue even with lower, yet unrelieved, mechanical stresses. Developing effective footwear and intervention strategies to prevent diabetic amputations requires a comprehensive approach which addresses multiple causative factors of foot ulceration and allows for the study of these unrelieved repetitive stresses. In this study, we will develop pressure alternating shoes (PAS) that will provide selective rest to the plantar aspect of the foot in order to prevent diabetic ulcers. The ultimate aim of this footwear will be to limit repetition of local plantar stresses, particularly at peak stress sites, and provide tissue an opportunity to recover. This periodic off-loading will also help prevent ischemic conditions in the plantar tissue, particularly in diabetic patients who stand for a long time. We will design and test the PAS to achieve the selective rest function and evaluate its safety, usability, biomechanical characteristics and comfort with healthy and diabetic subjects. This will be the first study on the effect of a device actively modulating the mechanical loading at the plantar surface for foot ulcer prevention and will allow for a systematic study of cyclical mechanical loading effects on foot ulcer formation which will advance understanding in the field of diabetic foot care. Ultimately, such a study has the potential to significantly impact the long term care of diabetics with a high prevalence of foot ulceration and improve their quality of life.