Dermatology and Cutaneous Surgery, University of Miami School of Medicine, Miami, Florida, USA.
BMJ Open. 2019 Jan 3;9(1):e023313. doi: 10.1136/bmjopen-2018-023313.
Chronic venous insufficiency (CVI) affects up to one-third of the adult population yet venous leg ulcers (VLU), a significant complication of CVI, only affect 1%-2% of adults in the USA. Why some develop VLU and others do not is unclear. VLU have a significant impact on quality of life and are extremely costly and difficult to treat. Moreover, VLU prevalence is increasing, doubling in the last 20 years. In order to characterise the differences between people with CVI and those who ultimately develop VLU, we aim to set up the unique venous insufficiency in South Florida cohort.
Subjects will be recruited from the University of Miami Hospital and Clinic's vascular laboratory database, which began in July 2011. Any adult age 18-95 who has had venous reflux detected on duplex ultrasound of the lower extremities is included. Approximately 2500 patients are already in the database that meet these criteria, with an estimated 2500 additional potential subjects to be recruited from the vascular laboratory database over the next 5 years. Subjects with a history of VLU prior to the duplex study date will be excluded. Data will be collected via review of the Doppler study report, patient phone interview and review of the electronic medical record. Subjects will be contacted for follow-up every 3 months for at least 5 years until the study endpoint, development of first VLU (fVLU), is reached. In order to estimate the time from reflux documentation to fVLU, Kaplan-Meier survival curves will be constructed. Cox proportional hazard regression models will be constructed to investigate possible risk factors.
This study is approved by the University of Miami's Institutional Review Board. We hope to present the results of this study to the scientific community at conferences and in peer-reviewed journals.
慢性静脉功能不全（CVI）影响了多达三分之一的成年人口，但静脉性腿部溃疡（VLU），CVI 的一个严重并发症，仅影响美国 1%-2%的成年人。为什么有些人会发展为 VLU，而有些人则不会，目前还不清楚。VLU 极大地影响了生活质量，并且极其昂贵且难以治疗。此外，VLU 的患病率正在增加，在过去 20 年中翻了一番。为了描述 CVI 患者和最终发展为 VLU 的患者之间的差异，我们旨在建立南佛罗里达独特的静脉功能不全队列。
将从迈阿密大学医院和诊所的血管实验室数据库中招募受试者，该数据库始于 2011 年 7 月。任何年龄在 18-95 岁之间的成年人，下肢双功能超声检查发现静脉反流的人都包括在内。数据库中已经有大约 2500 名符合这些标准的患者，预计在未来 5 年内，还将从血管实验室数据库中招募另外 2500 名潜在受试者。将排除在双功能超声研究日期之前有 VLU 病史的患者。将通过回顾多普勒研究报告、患者电话访谈和电子病历来收集数据。将每 3 个月对患者进行一次随访，至少随访 5 年，直到达到研究终点，即首次发生 VLU（fVLU）。为了估计从反流记录到 fVLU 的时间，将构建 Kaplan-Meier 生存曲线。将构建 Cox 比例风险回归模型来研究可能的危险因素。
本研究得到了迈阿密大学机构审查委员会的批准。我们希望在会议和同行评议期刊上向科学界介绍本研究的结果。
