Improving Diabetic Foot Ulcer Offloading: A Pilot Study on the Impact of Removable Cast Walker Design Factors on Usability

改善糖尿病足溃疡减轻负担：可拆卸石膏助行器设计因素对可用性影响的初步研究

• 批准号: 10521884
• 负责人: Ryan Crews
• 金额: $ 28.8万
• 依托单位: ROSALIND FRANKLIN UNIV OF MEDICINE & SCI
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10521884
• 关键词: Accelerometer; Address; Adherence; Amputation; Ankle; Area; Behavioral; Biomechanics; Clinical Trials; Complications of Diabetes Mellitus; Contralateral; Data; Development; Device Designs; Devices; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Diabetic Neuropathies; Disease; Equilibrium; Foot Diseases; Future; Gait; Goals; Guidelines; Individual; Interview; Kinetics; Knee; Lifting; Link; Literature; Measurement; Measures; Mediating; Medical Care Costs; Mental Depression; Methods; Mission; Monitor; Motion; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Participant; Patient Self-Report; Patients; Personal Satisfaction; Persons; Pilot Projects; Practice Guidelines; Process; Protocols documentation; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Reporting; Research; Sample Size; Self Efficacy; Series; Shoes; Stress; Surveys; Testing; Time; Uncertainty; United States National Institutes of Health; Variant; Walkers; Walking; Weight-Bearing state; Work; base; biomechanical test; chronic ulcer; cost; design; experience; falls; fear of falling; follow-up; foot; healing; improved; innovation; novel; patient oriented; predictive modeling; pressure; satisfaction; standard of care; tissue stress; usability; wound; wound healing

ABSTRACT Within their lifetime, over 30% of people living with diabetes will develop a diabetic foot ulcer (DFU), many of which will never heal and may require amputation. Removable cast walkers (RCWs) are commonly prescribed to offload (treat) DFUs. However, adherence with RCWs is low, which is a serious concern given that low adherence predicts poor DFU healing. There is an urgent need to address factors that hinder adherent use of RCWs to promote DFU healing. Our long-term goal is to optimize offloading adherence (OA), and subsequent DFU healing outcomes, by considering not only how much the device offloads the DFU, but also how much the device’s design impacts the patients’ experiences with the device. The objective of this proposal is to provide pilot/feasibility data to inform a definitive randomized controlled trial (RCT) that will evaluate the impact of existing RCW designs on OA and DFU healing and, secondarily, will facilitate development of a predictive model to guide patient-specific prescription of offloading devices. Our working hypothesis is that healing outcomes with a given RCW will be predicted by objective, biomechanical markers of RCW usability (e.g., measures of stability) and by RCW-induced changes in patient-reported factors, with the predictive relationship mediated by the effect of these measures on OA. We will consider three specific aims to achieve the objective and provide evidence to support our hypothesis and our ability to conduct a larger follow-up RCT: Aim 1: To examine the feasibility of conducting an RCT to evaluate the effects of RCW form on OA and DFU healing; Aim 2: To collect preliminary data to quantify the effect of RCW form on biomechanical markers of usability and patient-reported adherence factors in individuals with active DFU; and Aim 3: To collect preliminary data to evaluate the strength of associations between OA and both biomechanical markers of usability and patient-reported adherence factors. Across two study centers, participants will be randomized to use one-of-two RCW designs for four weeks in conjunction with weekly standard-of-care treatment. Throughout treatment, OA will be monitored using a novel dual accelerometer method and DFU healing will be quantified via planimetric wound area measurements. At the start of treatment participants will complete a series of surveys to assess patient-reported factors (e.g., depression). Patients will repeat surveys at the end of treatment and also perform several tests within a motion capture lab to assess aspects of RCW usability (e.g., stability & energetic costs of walking). The contribution of this work will be significant as it represents the next step in a continuum of research expected to improve DFU healing rates and reduce DFU complications including amputation, their associated medical costs and negative impact on well-being. The proposed study is innovative as it challenges current practice and guidelines by taking a patient-centered approach to DFU healing, which considers an offloading devices’ impact on the patient experience, rather than solely considering the devices’ functional offloading capacity.

摘要 在他们的一生中，超过30%的糖尿病患者会发展为糖尿病足溃疡(DFU)，许多 它永远不会痊愈，可能需要截肢。可拆卸石膏助行器(RCW)是常用的处方 卸载(治疗)DFU。然而，对RCWS的遵守程度很低，这是一个严重的问题，因为 坚持治疗预示着DFU愈合不良。迫切需要解决阻碍坚持使用的因素 RCWS促进DFU愈合。我们的长期目标是优化卸载遵从性(OA)，以及 后续DFU修复结果，不仅要考虑设备对DFU的减负程度，还要考虑 设备的设计对患者使用设备的体验有多大影响。这项提议的目的是 是提供试点/可行性数据，为最终的随机对照试验(RCT)提供信息，该试验将评估 现有RCW设计对OA和DFU愈合的影响，其次，将促进 预测模型，以指导患者特定的卸载设备处方。我们的工作假设是 特定RCW的愈合结果将通过RCW可用性的客观生物力学标记来预测 (例如，稳定性的测量)和RCW引起的患者报告因素的变化，具有预测性 通过这些措施对骨关节炎的影响而调节的关系。我们将考虑实现以下三个具体目标 目标和提供的证据支持我们的假设和我们进行更大规模后续行动的能力 随机对照试验：目标1：研究进行随机对照试验的可行性，以评估随机对照试验形式对骨性关节炎和骨质疏松症的影响 DFU愈合；目标2：收集初步数据以量化RCW形式对生物力学标志物的影响 活动期DFU患者的可用性和患者报告的依从性因素；以及目标3：收集 初步数据评估骨性关节炎与两种生物力学标志物之间的相关性 可用性和患者报告的依从性因素。在两个研究中心，参与者将被随机分配 在每周标准护理治疗的同时，使用两种RCW设计之一，为期四周。 在整个治疗过程中，将使用一种新的双加速度计方法监测OA，DFU愈合将 通过平面伤口面积测量来量化。在治疗开始时，参与者将完成一项 评估患者报告的因素(如抑郁症)的一系列调查。患者将在结束时重复调查 并在动作捕捉实验室内执行多项测试，以评估RCW可用性的各个方面 (例如，步行的稳定性和能量成本)。这项工作的贡献将是重大的，因为它代表了 有望提高DFU治愈率和减少DFU的连续研究的下一步 并发症包括截肢、相关的医疗费用和对福祉的负面影响。这个 拟议的研究具有创新性，因为它挑战了当前的实践和指南，采用了以患者为中心的 DFU治愈的方法，它考虑了卸载设备对患者体验的影响，而不是 而不是仅仅考虑设备的功能卸载能力。