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: 10654030
• 负责人: Ryan Crews
• 金额: $ 28.01万
• 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/10654030
• 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; Lower Extremity; 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; Process; Protocols documentation; Public Health; Quality of life; Randomized; Randomized, Controlled Trials; Reporting; Research; Sample Size; Self Efficacy; Series; Shoes; Stress; Surveys; Testing; Uncertainty; United States National Institutes of Health; Variant; Walking; Weight-Bearing state; Work; 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; walker; 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.

抽象的 在他们的一生中，超过30％的糖尿病患者会出现糖尿病足溃疡（DFU），许多 这将永远无法治愈，可能需要截肢。通常开处方的可移动铸造步行器（RCW） 卸载（治疗）dfus。但是，对RCWS的依从性很低，这是一个严重的问题，鉴于低 依从性预测DFU治疗差。迫切需要解决阻碍使用的因素 RCWS促进DFU愈合。我们的长期目标是优化卸载依从性（OA），并且 随后的DFU治疗结果，不仅考虑设备可卸载DFU的多少，还考虑 该设备的设计有多大影响患者对设备的体验。该提议的目的 是提供试点/可行性数据，以告知一项确定的随机对照试验（RCT），该试验将评估 现有的RCW设计对OA和DFU愈合的影响，次要将有助于发展 预测模型，以指导卸载设备的患者特定处方。我们工作的假设是 用给定的RCW的治疗结果将通过RCW可用性的客观生物力学标记来预测 （例如，稳定性的测量）和通过RCW诱导的患者报告因素的变化，并具有预测性 这些措施对OA的影响介导的关系。我们将考虑实现三个具体目标 目标并提供证据以支持我们的假设和进行更大随访的能力 RCT：目标1：检查进行RCT评估RCW形式对OA和OA的影响的可行性 DFU治疗；目标2：收集初步数据以量化RCW形式对生物力学标记的影响 活跃DFU患者的可用性和患者报告的依从性因素；目标3：收集 初步数据以评估OA与两个生物力学标记之间的关联强度 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 与每周的护理标准治疗一起使用两次RCW设计四个星期。 在整个处理过程中，将使用新型的双加速度计方法对OA进行监测，而DFU愈合将会 通过平面伤口区域测量进行量化。在治疗开始时，参与者将完成 评估患者报告因素的一系列调查（例如抑郁症）。患者将在最后重复调查 治疗并在运动捕获实验室内进行多项测试，以评估RCW可用性的各个方面 （例如，步行的稳定性和能源成本）。这项工作的贡献将非常重要，因为它代表 连续研究的下一步预计将提高DFU愈合率并降低DFU 并发症，包括截肢，其相关的医疗费用以及对幸福感的负面影响。 拟议的研究具有创新性，因为它通过以患者为中心来挑战当前的实践和准则 DFU治疗方法，它考虑了卸载设备对患者体验的影响，而是 而不是仅考虑设备的功能卸载能力。