Cryotherapy for Chronic Venous Disorders: A Pilot Study

描述（由申请人提供）：慢性静脉疾病（CVD）通常会导致经历CVD最严重表现的患者长期残疾：致残性疼痛和不愈合的腿部溃疡。这些残疾具有重大的社会经济影响，包括工作日和工资损失，生产力下降，最终增加医疗保健成本，使患有心血管疾病的人的健康和生活质量恶化。由于CVD没有可靠的预防机制，本研究提出了一种预防性的自我管理冷冻疗法干预，针对慢性腿部溃疡风险最高的CVD人群的炎症皮肤。拟议中的冷冻疗法干预将利用随机对照临床试验来开发一种方法，通过改善现有疗法来减少临床症状-它本身不是CVD的治疗方法。在拟议的初步可行性研究中，受试者将被随机分为两组： 冷冻治疗干预组（n=30），除了标准护理（常规护理）外，还将接受为期四周的冷冻治疗凝胶包裹，每天应用于小腿受影响的皮肤。对照组（n=30）将接受常规护理，即在小腿上使用加压包裹或长统袜，并每日抬高腿部。通过这种方法，可以观察到皮肤微循环的改善，腿部疼痛的减轻和生活质量的改善。以下目标将检验这一假设： 目标1.评估新干预的可行性，包括治疗保真度，受试者培训，安全性以及与设备和招募工作相关的副作用，并进一步完善干预方案，包括我们先前研究中使用的问卷。目标2.估计结果测量和效应量的变异性，以计算后续更大的、充分把握度的、随机临床试验的样本量，以评估新型冷冻治疗干预的疗效。 目标3。通过评估实验组皮肤温度和血流量降低程度更大、疼痛改善程度更大和生活质量改善程度更大的假设的统计学显著性趋势，研究实验治疗临床疗效的初步“信号”的存在。据预测，这种新的冷冻治疗模型和方法将显着改善CVD和相关疾病患者的健康和生活质量，并且干预将成为CVD的护理标准。此外，随着时间的推移，该方法将减少与治疗不良CVD结果相关的医疗保健成本。

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.