Cryotherapy for Chronic Venous Disorders: A Pilot Study

描述（由申请人提供）：慢性静脉疾病（CVD）通常会导致那些经历CVD最严重表现的人的长期残疾：致残疼痛和无法愈合的腿部溃疡。这种残疾在工作日和工资损失、生产力下降以及最终增加保健费用方面具有重大的社会经济影响，从而恶化了心血管疾病患者的福祉和生活质量。由于CVD没有可靠的预防机制，本研究提出了一种预防性、自我管理的冷冻治疗干预，针对CVD患者炎症皮肤的慢性腿部溃疡风险最高的人群。拟议的冷冻疗法干预将利用一项随机对照临床试验来开发一种通过改进现有疗法来减少临床症状的方法——它本身不是一种治疗心血管疾病的方法。在拟议的试点可行性研究中，受试者将被随机分为两组

DESCRIPTION (provided by applicant): Chronic venous disorders (CVD) often cause long-term disability for those who experience the worst manifestations of CVD: disabling pain and non-healing leg ulcers. Such disabilities have significant socioeconomic implications in terms of lost work days and wages, decreased productivity, and ultimately increased health cares costs that deteriorate the well-being and quality of life for those who have CVD-induced illnesses. Because no reliable preventive mechanism exists for CVD, this study proposes a preventive, self management cryotherapy intervention that targets inflamed skin of populations with CVD at highest risk of developing chronic leg ulcers. The proposed cryotherapy intervention will utilize a randomized controlled clinical trial to develop a method to reduce clinical symptoms by improving existing therapy-it is not a treatment for CVD itself. In the proposed pilot feasibility study, subjects will be randomized to two groups: the cryotherapy intervention group (n=30) who will receive a four-week, cryotherapy gel wrap applied daily to affected skin of the lower legs in addition to the standard of care (usual care). The control group (n=30) will receive the usual care of compression wraps or stockings applied to the lower legs and daily leg elevation. With this method, improvement of skin microcirculation, reduced leg pain, and improvement in quality of life will be observed. The following aims will test the hypothesis: Aim 1. Evaluate the feasibility of the novel intervention including treatment fidelity, subject training, safety, and side effects associated with equipment and recruitment efforts and further refine the intervention protocol, including questionnaires used in our previous studies. Aim 2. Estimate variability of outcome measurements and effect sizes needed to calculate sample size for a subsequent larger, adequately powered, randomized clinical trial of the efficacy of the novel cryotherapy intervention. Aim 3. Investigate the presence of a preliminary "signal" of clinical efficacy of the experimental treatment by evaluating trends toward statistical significance for the hypothesis that the experimental group will experience greater reduction in skin temperature and blood flow, greater improvement in pain, and greater improvement in quality of life. It is predicted that this novel cryotherapy model and method will significantly improve the health and quality of life for those with CVD and related disorders, and that the intervention will become the standard of care for CVD. In addition, the method will, over time, reduce health care costs associated with treating poor CVD outcomes.