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

使用智能卸载提高糖尿病足溃疡患者的依从性强化和安全活动科学

• 批准号: 10534141
• 负责人: DAVID George ARMSTRONG
• 金额: $ 40.93万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2025-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10534141
• 关键词: Acceleration; Address; Adherence; Amputation; Ankle; Cellular Phone; Chronic; Clinic; Clinical; Clinical Management; Clinical Trials; Complex; Complications of Diabetes Mellitus; Control Groups; Counseling; Data; Devices; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Enrollment; Exercise; Feedback; Foot Ulcer; Health Care Costs; Immobilization; Impaired healing; Impaired wound healing; Impairment; Leg; Life; Limb structure; Lower Extremity; Measures; Monitor; Muscle; Muscular Atrophy; Nature; Neuropathy; Notification; Outcome; Pain; Participant; Patient-Focused Outcomes; Patients; Performance; Personal Satisfaction; Persons; Physical activity; Polysomnography; Prevention; Psychological reinforcement; Randomized; Recurrence; Reporting; Research; Science; Sleep; Speed; Syndrome; Time; Treatment Cost; Ulcer; Walking; Weight-Bearing state; World Health Organization; ankle joint; appropriate dose; arm; chronic wound; comparative; comparative effectiveness study; compliance behavior; cost; deconditioning; diabetes management; diabetic; disability burden; dosage; foot; frailty; group intervention; healing; improved; improved mobility; innovation; mHealth; mortality; new technology; patient mobility; poor sleep; pressure; prevent; remote patient monitoring; sensor; sleep quality; smart watch; standard care; treatment arm; treatment as usual; walker; wound; wound healing

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).

项目摘要/摘要 我们旨在减少神经性糖尿病足溃疡（DFU）的威胁肢体威胁和限制生命的烧伤 通过在其最关键的组成部分中推进科学：保护压力卸载。我们打算通过 有史以来第一个智能可移动装置（MOTU）的随机比较有效性研究 Smart），可以客观地监视依从性和依从性增强（实时 通过智能手表 +反馈通过智能手机通知依从性差）。 规定的卸载，例如可移动的铸造步行者（RCW），用于降低底部的压力 保护DFU的脚。这使其可以在允许患者移动的同时愈合。这些设备可以是 DFU治愈和预防的关键组成部分。不幸的是，对这些设备的耐心依从性是 贫穷的。尽管不可忽视的卸载设备可以应对这一挑战，但他们还有其他局限性 可接受性差（由于睡眠和淋浴期间的不可算可力），因此可伸缩性差（例如，只有2％ 美国诊所定期开处方这种金色标准疗法），以患者为中心的不良结果（例如，差 睡眠质量），高卸载引起的很可能会导致脱离（弱/腿部肌肉萎缩），因为 长时间的踝关节固定，导致DFU复发率高。另一个科学差距 对体重活动对足底伤口愈合的影响的理解不足。一些报告 即使佩戴受保护的卸载，这种常规的承重活动也可能会延迟愈合。其他人建议 稳定且适当的剂量受保护体重运动有益于加速愈合。 鉴于DFU的衰弱性质和高昂的治疗成本，需要新颖 没有正常疼痛反馈以遵守的动机神经性患者的技术方法 处方卸载并使临床医生能够监视和咨询患者的体育锻炼 和坚持。在这项研究中，我们将招募216名随机活性DFU的非卧床患者 组（比率：n = 1：1：1）。第一组包括金色标准疗法，不可移靴子（该靴子 患者坚持以保护压力的卸载）。第二组包括一个相同的 配备了传统的可移动设备以及有关依从性的重要性的传统咨询 卸载。第三组将包括一个“智能”可移动式助行器，其中包括依从性 加强和远程患者监测。这三个组的所有设备都将嵌入 允许监视依从性和活动。这项研究使我们能够检查依从性的好处 加强加快伤口愈合的加固（AIM 1）；体育锻炼剂量之间的关联 和伤口愈合（AIM 2）；三个治疗组之间以患者为中心的结果（AIM 3）。