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: 10322036
• 负责人: DAVID George ARMSTRONG
• 金额: $ 40.92万
• 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/10322036
• 关键词: 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; Gold; Health Care Costs; Immobilization; Impaired healing; Impaired wound healing; Impairment; Lead; 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; Walkers; Walking; Weight-Bearing state; World Health Organization; ankle joint; appropriate dose; arm; base; 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; novel; patient mobility; poor sleep; pressure; prevent; remote patient monitoring; sensor; sleep quality; smart watch; standard care; treatment arm; treatment as usual; 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 我们的目标是减轻神经性糖尿病足溃疡(DFU)威胁肢体和限制生命的负担。 通过在其最关键的部分：保护压力卸载方面推进科学。我们打算通过一个 首个智能可拆卸装置(MOTUS)的随机比较效果研究 SMART)，从而实现对遵从性的客观监控以及遵从性强化(实时 通过智能手表通知遵守情况不佳+通过智能手机进行反馈)。 规定的卸载，如可拆卸的石膏(RCW)，用于减少底部的压力 保护DFU的脚。这使得它可以在治愈的同时允许患者移动。这些设备可以是 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 可怜。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 可接受性差(因为它在睡眠和淋浴时不可拆卸)，可扩展性差(例如，只有2% 美国诊所经常开这种黄金标准疗法)，以患者为中心的不良结局(例如，不良 睡眠质量)，以及由减负引起的条件解除(虚弱/腿部肌肉萎缩)的可能性很高，因为 踝关节制动时间延长导致DFU复发率高。世界上另一个科学空白 该领域对负重活动对足底伤口愈合的影响知之甚少。一些报道 有规律的负重活动，即使是在戴着保护性卸荷装置的情况下，也可能会推迟愈合。其他人则建议 稳定、适量的保护性负重运动有利于加速愈合。 鉴于DFU的衰弱性质和高昂的治疗成本，有必要开发新的 激励没有正常疼痛反馈的神经病患者坚持的技术方法 规定的减量，并使临床医生能够监测和咨询患者的体力活动 和坚持不懈。在这项研究中，我们将招募216名活动期DFU患者，随机分为3组 组(比例：n=1：1：1)。第一组包括黄金标准治疗，一种不可拆卸的靴子(它迫使 患者坚持保护性卸压)。第二组包括在其他方面相同的 配备了传统的可拆卸设备以及关于坚持的重要性的传统咨询 到卸货。第三组将包括一个智能的可拆卸的石膏步行器，它包括粘性 增援和远程患者监护。这三家公司的设备都将嵌入传感器， 允许监控遵从性和活动。这项研究使我们能够检查坚持下去的好处 加强以加速伤口愈合(目标1)；体力活动剂量之间的联系 和伤口愈合(目标2)；以及三个治疗部门之间以患者为中心的结果(目标3)。