Preventing Venous Leg Ulcers with Cryotherapy: A Randomized Clinical Trial

描述(由申请人提供)：一项初步研究表明，在四周的高强度冷冻治疗干预后，冷却受静脉疾病影响的发炎皮肤显著减少血流量。这项新的试验将评估这种以家庭为基础的冷冻干预措施的有效性，方法是在30天的密集冷冻期后增加顺序逐渐减少的冷却。其目的是减少慢性炎症皮肤的皮肤血流量，降低静脉性腿部溃疡和疼痛的发生率，提高生活质量。人们经常尝试无数的外科、药理学和非药理学疗法，如压迫绷带，但许多都收效甚微。超过70%的静脉功能不全患者会出现浮肿、皮肤损伤和溃疡。预防溃疡是有必要的，因为这对损失工作日和工资、降低生产力和增加医疗费用具有重大的社会经济影响。临床医生专注于多种治疗方法，往往没有考虑患者如何为自己的自我护理做出贡献。我们为期9个月的干预是基于涉及微循环的传热学原理和冷冻治疗理论。根据冷冻治疗专家和完成R21试验的参与者的意见，我们提出了一种顺序干预策略，在第一个月每天冷却30分钟，然后在2-3个月减少到每周两次，4-6个月每周一次，然后在7-9个月减少到每周一次。我们将在1、3、6和9个月后测量血流、皮温、疼痛、生活质量和腿部溃疡的发生率。符合条件的参与者将被随机分为治疗组(低压缩冷敷布)或常规护理(低压缩非冷敷布)。两组的参与者都将收到所有与学习相关的材料，包括标准化指导、皮肤温度计、特别设计的低压缩包裹、腿部提升机枕头和压缩袜子，并在深入的迎新会议期间接受。我们假设冷冻治疗将加强基本上无效的非药物自我护理的日常护理模式，即告诉患者穿压缩袜子，抬起腿，并进行更多的锻炼。这些战略通常不足以实现可持续的变革。在我们的研究方法中，我们包括严格的过程、影响和结果监测。在一个期待技术和药物“修复”的时代，这种自我护理策略如果有效，可能是一种经济的方式，可以减少数以千计的患者的发病率和疼痛，这些患者经常被视为对自我护理没有反应。预防溃疡也是节省医疗费用的一个主要潜在来源。考虑到静脉疾病的负担，人群的复杂身体特征，包括过度肥胖和并存，以及需要为患者提供可行的、激励的和支持性的战略来促进自我护理，这项试验具有重要意义。目标是为预防建立一个新的实践标准。

DESCRIPTION (provided by applicant): A Pilot study demonstrated that cooling inflamed skin affected by venous disorders significantly reduced blood flow after a four-week intense cryotherapy intervention. This new trial will assess the efficacy of this home-based cryotherapy intervention by adding sequenced tapered cooling after a 30-day intense cooling period. The goal is to reduce skin blood flow of chronically inflamed skin, decrease the incidence of venous leg ulcers and pain, and improve quality of life. A myriad of surgical, pharmacologic, and non-pharmacologic therapies such as compression bandages are often tried, many with limited success. More than 70% of patients with venous disorders such as insufficiency develop edema, skin damage, and ulcers. Ulcer prevention is warranted because of the significant socioeconomic implications in terms of lost workdays and wages, decreased productivity and increased health care costs. Clinicians focus on the multiple treatment approaches, often without consideration of how patients can contribute to their own self-care. Our 9-month intervention is based on principles of heat transfer and cryotherapy theories involving microcirculation. With input from a cryotherapy expert and participants who completed the R21 pilot, we propose a sequenced intervention strategy, where cooling will be dosed daily for 30 minutes for the first month, and then decreased to twice weekly dosing in months 2-3, once weekly in months 4-6, then PRN in months 7-9. We will measure blood flow, skin temperature, pain, quality of life, and the incidence of leg ulcers after months 1, 3, 6 and 9. Eligible participants will be randomized to treatment (low compression cooling wrap) or usual care (low compression non-cooling "sham" wrap). Participants in both groups will receive all study related materials including standardized instruction, skin thermometer, specially designed low compression wraps, leg elevator pillow, and compression stockings, and during an in-depth orientation session. We hypothesize that cryotherapy will enhance the largely ineffective non-pharmacologic self-care usual care model, that is, telling patients to wear compression stockings, elevate the legs, and get more exercise. These strategies are generally inadequate in achieving sustained change. Among our research methods we include rigorous process, impact and outcome monitoring. In an era of expectation for technological and pharmaceutical "fixes", this self-care strategy, if efficacious, could be an economical way to decrease morbidity and pain for thousands of patients, frequently viewed as non-responsive to self care. Prevention of ulcers is also a major potential source of saved medical dollars. This trial is significant due to the burden of venous disorders, the complex physical characteristics of the population including excessive obesity and co-morbidity and the need to reach patients with a feasible, motivational, and supportive strategy to promote self-care. The objective is to establish a new practice standard for prevention.