Pressure Alternating Shoes for Prevention of Diabetic Foot Ulcers

摘要 糖尿病足溃疡继续给美国医疗保健系统和患者带来负担，估计每年的费用为 300亿美元和10万例截肢率然而，这个问题的确切病因仍有待解决。 已知它是多因素的。糖尿病足病变具有生物力学病理学， 压力作用在脚下;然而，足部压力本身并不是溃疡的良好预测因素，因为溃疡是 已知在不被认为有害的压力水平下发生。关于以下病理作用的结果： 足底剪切还没有定论。预防鞋，旨在解决只有高峰压力， 在预防溃疡方面表现出较差的成功，这进一步表明病理学是多因素的。一个 关于溃疡形成的另一种理论认为糖尿病周围神经病变会导致 糖尿病患者的足底负荷，这可能因此导致组织压痛和破裂。 健康的人已经被证明可以根据感觉反馈改变他们的负荷模式，这可以防止 局部组织压痛和疼痛。由于神经病变，糖尿病足的某些区域 认为经历重复的压力，而不是缓解不适或疼痛，这些 压力会产生。长时间重复可能导致组织失效，即使使用较低但未缓解的， 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足部溃疡的多种致病因素， 来研究这些无法缓解的重复性压力在本研究中，我们将开发压力交变鞋 (PAS)这将为足部的足底方面提供选择性的休息，以防止糖尿病溃疡。的 这种鞋的最终目的是限制局部足底应力的重复，特别是在峰值应力位置， 为组织提供恢复的机会这种周期性的卸载也有助于防止缺血性 在足底组织的条件，特别是在糖尿病患者谁站了很长一段时间。我们将设计和 测试PAS的选择性休息功能，评价其安全性、可用性、生物力学 健康和糖尿病受试者的特征和舒适度。这将是第一个研究的影响， 主动调节足底表面处的机械负荷以预防足部溃疡的装置 对于周期性机械负荷对足部溃疡形成的影响的系统研究， 了解糖尿病足护理领域。最终，这样的研究有可能对 长期护理糖尿病足溃疡患病率高，提高他们的生活质量。

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.