Improving the science of adherence reinforcement and safe mobility in people with diabetic foot ulcers using smart offloading

项目总结/摘要 我们的目标是减少神经病变性糖尿病足溃疡（DFU）对肢体的威胁和对生命的限制 通过在其最关键的组成部分：保护性压力卸载方面推进科学。我们打算通过一个 首个智能可移动卸载装置（MOTUS）的随机比较有效性研究 智能），可实现对依从性的客观监控以及依从性强化（实时 通过智能手表通知不良依从性+通过智能电话反馈）。 规定的卸载，例如可移动的石膏步行者（RCW），用于减少 脚来保护DFU。这允许它愈合，同时允许患者移动的。这些设备可以 治疗和预防DFU的关键组成部分。不幸的是，患者对这些设备的依从性 扶贫虽然不可拆卸的卸载设备可以解决这一挑战，但它们也有其他限制，包括 差的可接受性（因为其在睡眠和淋浴期间不可移除），差的可扩展性（例如，只有2%的 美国诊所定期规定这种黄金标准疗法），以患者为中心的不良结果（例如，贫困 睡眠质量），以及由卸载引起的失调（虚弱/腿部肌肉萎缩）的高可能性，因为 长期踝关节制动导致DFU复发率高。另一个科学空白 Field对负重活动对足底伤口愈合的影响了解不多。有些报告 即使在穿着保护卸载的情况下，定期的负重活动也可能会延迟愈合。还有人建议 稳定且剂量适当的保护性负重运动有利于加速愈合。 鉴于DFU的衰弱性质和治疗的高成本，需要新的治疗方法。 激励没有正常疼痛反馈的神经病患者坚持的技术方法 并使临床医生能够监测和咨询患者的身体活动 和坚持。在这项研究中，我们将入组216名患有活动性DFU的非卧床患者，随机分为3组， 组（比例：n=1：1：1）。第一组包括黄金标准的治疗，一个不可移动的靴子（这迫使 患者坚持保护性减压）。第二组包括在其他方面相同的 沿着传统的关于坚持重要性的咨询 到卸货。第三组将包括一个“智能”可移动石膏步行者，包括坚持 加强和远程患者监测。这三个小组的设备都将嵌入传感器， 允许监控依从性和活动。这项研究使我们能够检查坚持的好处 加强以加速伤口愈合（目的1）;体力活动剂量之间的关联 和伤口愈合（目标2）;以及三个治疗组之间以患者为中心的结局（目标3）。

PROJECT SUMMARY/ABSTRACT We aim to reduce the limb-threatening and life-limiting burden of neuropathic diabetic foot ulcers (DFU) by advancing science in its most critical component: protective pressure offloading. We intend to do this via a randomized comparative effectiveness study of a first-ever smart removable offloading device (MOTUS Smart), which enables objective monitoring of adherence as well as adherence reinforcement (real-time notification of poor adherence via smartwatch + feedback via smartphone). Prescribed offloading, such as a removable cast walker (RCW), is used to reduce pressure on the bottom of the foot to protect the DFU. This allows it to heal while allowing the patient to be mobile. These devices can be a key component of healing and prevention of DFU. Unfortunately, patient adherence with these devices is poor. While irremovable offloading devices could address this challenge, they have other limitations including poor acceptability (because of its irremovability during sleep and shower), poor scalability (e.g., only 2% of U.S. clinics regularly prescribe this gold-standard therapy), poor patient-centered outcomes (e.g., poor sleep quality), and high likelihood of deconditioning (frailty/leg muscle atrophy) induced by offloading because of prolonged ankle joint immobilization leading to high recurrence rate of DFU. Another scientific gap in the field is poor understanding of the influence of weight-bearing activity on plantar wound healing. Some report that regular weight-bearing activity even while wearing protected offloading may delay healing. Others suggest that stable and appropriately dosed protected weight-bearing exercise is beneficial to accelerate healing. Given the debilitating nature of DFU and the high cost of treatment, there is a need for novel technological approaches to motivate neuropathic patients without normal painful feedback to adhere to prescribed offloading and to enable clinicians to monitor and counsel patients on physical activity and adherence. In this study, we will enroll 216 ambulatory patients with active DFU randomized to three groups (ratio: n=1:1:1). The first group includes the gold-standard treatment, an irremovable boot (which forces patients into adhering to protective offloading of pressure). The second group includes an otherwise identically equipped traditional removable device along with traditional counseling regarding the importance of adherence to offloading. The third group will include a “smart” removable cast walker that includes adherence reinforcement and remote patient monitoring. All three groups’ devices will be embedded with sensors that will allow monitoring of adherence and activity. This study enables us to examine the benefit of adherence reinforcement to speed up wound healing (Aim 1); the association between dosage of physical activity and wound healing (Aim 2); and patient-centered outcomes between the three treatment arms (Aim 3).