Feasibility and effectiveness of a pilot remote monitoring program for the treatment of diabetic foot ulcers

项目总结/摘要 凯特琳·W Hicks医学博士，理学硕士，约翰霍普金斯大学外科系外科副教授 大学医学院。她目前拥有K23辅导职业发展奖， NIDDK专注于糖尿病周围神经病变的危险因素、结局和蛋白质组学。她寻求一个 R 03奖将她的研究重点扩大到临床试验，这将为她的研究和临床管理提供信息 患有糖尿病和下肢并发症的成年人。希克斯博士的研究计划详细介绍了 一种新型远程伤口监测程序治疗糖尿病的随机对照可行性试验 足部溃疡（DFU）。研究议程的具体目标是：1）建立一个小说的可行性 以患者为中心的远程监测程序，用于监测和监控DFU; 2）评估患者 与标准现场监控相比，远程DFU监控技术的供应商满意度; 和3）生成关于DFU患者伤口愈合时间和主要截肢风险的初步数据， 与接受标准治疗的DFU患者相比，一百二十个病人 将以1：1的比例进行计算机随机分配，使用远程DFU监测技术接受伤口护理监测，或 进行为期12周的标准现场监测。入组远程伤口监测技术组的患者 我将使用智能手机应用程序每周上传伤口照片到一个专门的门户网站， 可以随时间监测伤口进展，并在入组时参加计划的亲自随访，第4周， 第8周和第12周。将为随机接受标准治疗的患者提供伤口护理计划 入组时，然后每两周在诊所进行一次随访（第2、4、6、8、10、12周）， 个人创伤评估成果将包括技术可行性（定义为参与者人数 每周成功完成至少一次远程伤口扫描的人）;患者参与度和应用程序可用性， 患者满意度和提供者满意度（基于研究时的离散和开放式调查问题 完成）;和12周时伤口尺寸减小（%）、伤口愈合时间（天）和大截肢。 本研究将提供有关使用远程DFU监测技术的可行性的可操作数据， 弱势患者，可能改善患者满意度和伤口愈合结局， 标准的现场监控结果将提供初步数据，以支持R 01赠款提交， 将在一项大型随机临床试验中严格评估这项技术。通过提供试点和 可行性数据，以帮助支持后续的R 01，这R 03的建议将提高希克斯博士的能力， 过渡到独立调查员。

PROJECT SUMMARY/ABSTRACT Caitlin W. Hicks MD, MS is an Associate Professor of Surgery in the Department of Surgery at Johns Hopkins University School of Medicine. She currently holds a K23 Mentored Career Development Award from the NIDDK focused on the risk factors, outcomes, and proteomics of diabetic peripheral neuropathy. She seeks an R03 award to expand her research focus to a clinical trial that will inform her research and clinical management of adults with diabetes and lower extremity complications. Dr. Hicks’ research proposal details a pilot randomized controlled feasibility trial of a novel remote wound monitoring program for the treatment of diabetic foot ulcers (DFUs). The specific aims of the research agenda are to 1) Establish the feasibility of a novel remote patient-centered monitoring program for the surveillance and monitoring of DFUs; 2) Assess patient and provider satisfaction with remote DFU monitoring technology compared to standard in-person monitoring; and 3) Generate pilot data on wound healing time and major amputation risk in patients with DFU who are monitored remotely compared to DFU patients treated with standard of care. One-hundred and twenty patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks. Patients enrolled in the remote wound monitoring technology arm will upload weekly wound photos using a smartphone application to a dedicated portal where the care team can monitor the wound progression over time, and attend scheduled in-person follow-up at enrollment, week 4, week 8, and week 12. Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for an in- person wound assessment. Outcomes will include technology feasibility (defined as the number of participants who successfully complete at least one remote wound scan per week); patient engagement and app usability, patient satisfaction, and provider satisfaction (based discrete and open-ended survey questions at study completion); and wound size reduction at 12 weeks (%), wound healing time (days), and major amputation. This study will provide actionable data about the feasibility of using remote DFU monitoring technology in disadvantaged patients, possibly improving patient satisfaction and wound healing outcomes compared to standard in-person monitoring. The results will provide preliminary data to support a R01 grant submission that will rigorously evaluate this technology in the setting of a large randomized clinical trial. By providing pilot and feasibility data to help support a subsequent R01, this R03 proposal will enhance the capability of Dr. Hicks to transition to an independent investigator.