Tele-FootX: Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing

摘要 足溃疡是糖尿病最常见和最昂贵的晚期并发症，发病率和死亡率是糖尿病的主要并发症。 比很多癌症都严重。据估计，高达三分之一的糖尿病患者会患上糖尿病足 溃疡（DFU）在其一生中。不愈合DFU是住院、截肢、残疾和 糖尿病患者的死亡率。在美国，三分之一的糖尿病相关费用用于 糖尿病足护理，三分之二的费用发生在住院设置，构成了一个巨大的经济 社会的负担。因此，应尽一切可能治愈DFU并防止截肢。 在这方面，有大量证据表明，运动对患有糖尿病的人有临床益处。 DFU，包括改善血液流动和氧气供应，预防肌肉流失和关节活动。尽管如此 证据表明，运动不是伤口愈合的标准护理的一部分，主要是因为没有促进伤口愈合的解决方案。 并为DFU患者管理家庭锻炼计划。 在第一阶段SBIR项目中，我们将为DFU患者设计一个互动式足部和踝关节锻炼计划 使用名为Tele-FootX™的可穿戴传感器。Tele-FootX将实现远程和虚拟监督 基于证据的足部和踝关节锻炼，并允许临床医生教育，监测和指导患者。的 平台的游戏特征将促进对规定的锻炼计划的坚持，并且，随后， 伤口愈合这种方法得到了我们的概念验证研究的支持，在该研究中，我们证明了 交互式足部和踝关节练习，以改善下肢灌注并增加小腿活动 肌肉.为了实现这一目标，在目标1中，我们将设计一个互动的游戏为基础的锻炼平台，使用脚- 安装传感器，并通过包括基于游戏的练习，使其适合DFU的人， Buerger-Allen锻炼计划。在目标2中，我们将证明以下方面的可接受性、可行性、安全性和证据 Tele-FootX在改善下肢灌注方面的概念有效性，招募15名参与者， DFU。我们将检查感知的好处、易用性、技术接受度、可用性和技术 从目标2招募的15名DFU参与者以及10名健康护理人员的角度来看， 拥有DFU管理专业知识的专业人员。 在第二阶段，我们将推出新的游戏功能，以提高参与度，以及临床医生的功能， 教育、管理和个性化每个患者的家庭锻炼计划。我们还将整合 现有医院记录和远程评估的建议解决方案（例如，EPIC）。我们将验证最终的 在一项为期12周的随机对照试验中。有现有的CPT代码，涵盖远程锻炼计划。 报销代码（CPT代码98975、98977、98980和98981）的存在， 市场（全球每年有2610万人开发DUF），以及拟议的 解决方案将促进Tele-FootX的商业化。

Abstract Foot ulceration is the most common and costly late complication of diabetes, with morbidity and mortality being worse than many cancers. It is estimated that up to one-third of people with diabetes will develop a diabetic foot ulcer (DFU) in their lifetime. Non-healing DFUs are a leading cause of hospitalization, amputation, disability, and death among people with diabetes. In the United States, one-third of all diabetes-related costs are spent on diabetic foot care, with two-thirds of the costs incurred in inpatient settings, constituting a substantial economic burden to society. Therefore, every means possible should be used to try to heal DFU and prevent amputation. In this regard, there is a significant body of evidence related to the clinical benefits of exercise for people with DFU, including improving blood flow and oxygen supply, muscle loss prevention, and joint mobility. Despite this evidence, exercise is not part of the standard care for wound healing, mainly as there is no solution for promoting and managing home-based exercise programs for people with DFU. In this Phase I SBIR project, we will design an interactive foot and ankle exercise program for people with DFU using wearable sensors called Tele-FootX™. Tele-FootX will enable both remotely and virtually supervised evidence-based foot and ankle exercises and allow clinicians to educate, monitor, and coach patients. The gaming features of the platform will promote adherence to the prescribed exercise programs, and, subsequently, wound healing. This approach is supported by our proof-of-concept study, where we demonstrated the benefit of interactive foot and ankle exercises to improve lower extremity perfusion and increase activity in the calf muscle. To achieve this goal, in Aim 1, we will design an interactive game-based exercise platform using foot- mounted sensors and make it suitable for people with DFU by including game-based exercises inspired by the Buerger-Allen exercise program. In Aim 2, we will demonstrate the acceptability, feasibility, safety, and proof of concept effectiveness of the Tele-FootX in improving lower extremity perfusion by recruiting 15 participants with DFU. We will examine the perceived benefit, ease of use, technology acceptance, usability, and technology anxiety from the point of view of the 15 participants with DFU recruited in Aim 2, as well as 10 health care professionals with expertise in DFU management. In Phase II, we will introduce new gaming features to improve engagement, as well as features for clinicians to educate, manage and personalize the home-based exercise program for each patient. We will also integrate the proposed solution into existing hospital records and remote assessments (e.g., EPIC). We will validate the final product in a 12-week randomized control trial. There are existing CPT codes that cover tele-exercise programs. The existence of reimbursement codes (CPT codes 98975, 98977, 98980, and 98981), the large size of the market (26.1 million worldwide develop DUF annually), and the significant clinical benefits of the proposed solution will facilitate commercialization of Tele-FootX.