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，在为期四周的强烈冷冻治疗干预后，冷却受静脉疾病影响的发炎皮肤可显著减少血流量。这项新的试验将通过在30天的强烈冷却期后增加顺序锥形冷却来评估这种基于家庭的冷冻治疗干预的有效性。目的是减少慢性炎症皮肤的皮肤血流量，降低下肢静脉溃疡和疼痛的发生率，并改善生活质量。经常尝试无数的手术，药物和非药物治疗，如压迫绷带，许多成功有限。超过70%的静脉疾病患者（如功能不全）会出现水肿、皮肤损伤和溃疡。溃疡预防是必要的，因为在工作日和工资损失，生产力下降和医疗保健成本增加方面的重大社会经济影响。临床医生专注于多种治疗方法，通常不考虑患者如何为自己的自我护理做出贡献。我们的9个月的干预是基于传热原理和涉及微循环的冷冻疗法理论。根据冷冻治疗专家和完成R21试点的参与者的意见，我们提出了一种顺序干预策略，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给药，第4-6个月每周一次，然后在第7-9个月进行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。合格的受试者将被随机分配至治疗组（低压缩冷却包裹）或常规护理组（低压缩非冷却“假”包裹）。两组的受试者将在深入的定向会议期间收到所有研究相关材料，包括标准化指导、皮肤温度计、专门设计的低压缩包裹、腿部升降机枕头和压缩袜。我们假设，冷冻疗法将加强基本无效的非药物自我护理的常规护理模式，即告诉患者穿压缩袜，抬高腿部，并得到更多的锻炼。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。在一个期望技术和药物“修复”的时代，这种自我护理策略，如果有效的话，可能是一种经济的方式，以减少成千上万的患者的发病率和疼痛，经常被视为对自我护理无反应。预防溃疡也是节省医疗费用的主要潜在来源。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、激励性的和支持性的策略以促进自我护理，因此本试验具有重要意义。目的是建立一个新的预防实践标准。 公共卫生相关性：这项研究测试了在9个月的研究期间，一种创新的低压缩冷凝胶包裹（冷冻疗法）应用于慢性静脉疾病引起的皮肤慢性炎症是否会减少皮肤血流量，降低皮肤温度，并减少静脉性腿部溃疡的发生率。我们的序列干预增强了当前的临床实践，更重要的是，测试了一种高度可行的低成本策略，可以减少疼痛，改善数百万人的发病率和生活质量。

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. PUBLIC HEALTH RELEVANCE: This study tests whether an innovative low compression cool gel wrap (cryotherapy) applied to skin chronically inflamed by chronic venous disorders will reduce skin blood flow decrease skin temperature, and reduce the incidence of venous leg ulcers during the 9-month study period. Our sequenced intervention augments current clinical practices, and-more importantly-tests a highly feasible, low-cost strategy that could reduce pain and improve morbidity and quality of life for millions of individuals.