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，在为期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着减少了血流量。这项新试验将评估这种基于家庭的冷冻治疗干预的效果，方法是在30天的高强度冷却期后加入顺序逐渐冷却。目的是减少慢性炎症皮肤的皮肤血流量，减少腿部静脉溃疡和疼痛的发生率，提高生活质量。无数的手术，药物和非药物治疗，如压缩绷带经常尝试，许多有限的成功。超过70%的静脉功能不全患者会出现水肿、皮肤损伤和溃疡。预防溃疡是必要的，因为它在工作日和工资损失、生产力下降和保健费用增加方面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有助于他们自己的自我保健。我们为期9个月的干预是基于涉及微循环的传热原理和冷冻疗法理论。根据冷冻治疗专家和完成R21试验的参与者的意见，我们提出了一个有序的干预策略，在第一个月，每天给药30分钟，然后在第2-3个月减少到每周两次，在第4-6个月减少到每周一次，然后在第7-9个月减少到PRN。我们将在第1、3、6和9个月后测量血流量、皮肤温度、疼痛、生活质量和腿部溃疡的发生率。符合条件的参与者将随机分配到治疗组（低压缩冷却包裹）或常规护理组（低压缩非冷却“假”包裹）。两组参与者都将收到所有与研究相关的材料，包括标准化的指导、皮肤温度计、专门设计的低压缩包装、腿部提升枕和压缩袜，并在深入的培训期间。我们假设冷冻疗法将加强大部分无效的非药物自我保健常规护理模式，即告诉患者穿压缩袜，抬高腿，多锻炼。这些战略一般不足以实现持续的变革。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，这种自我保健策略如果有效，可能是一种经济的方式，可以减少成千上万的患者的发病率和痛苦，这些患者通常被认为对自我保健没有反应。预防溃疡也是节省医疗费用的一个主要潜在来源。由于静脉疾病的负担，人群的复杂身体特征，包括过度肥胖和合并症，以及需要为患者提供可行的，有动机的和支持性的策略来促进自我保健，因此该试验具有重要意义。目标是建立一种新的预防做法标准。

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.