Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence

 描述（由申请人提供）：本随机对照试验的目的是测试患者指导的自我监测和自我管理干预，旨在使用皮肤温度和冷冻疗法（冷却）预防慢性下肢静脉溃疡和糖尿病足溃疡复发。我们提出了MUSTCOOL，一种新的溃疡预防策略，用于慢性溃疡风险最高的患者;有既往史的患者。我们的目的是比较冷却治疗与安慰剂，以确定溃疡复发，疼痛，体力活动和生活质量的结果。新治愈的慢性溃疡患者将被邀请参加MUSTCOOL的两部分干预：1）每天用红外线温度计自我监测目标“热点”的皮肤温度; 2）每周三次在“热点”上放置冷却包（或安慰剂包），持续30分钟。如果“热点”的温度连续2天高于基线（30天每日温度读数的平均值）2°F，则将实施连续5天、每天30分钟应用冷却或安慰剂包的推注方案。我们将监测安全性和副作用，然而，在我们以前的冷冻治疗研究中没有报告不良事件。我们设计了这种慢性溃疡预防干预措施，其目标是重塑阶段，即慢性溃疡闭合后愈合的最终修复过程。由于持续的异常炎症状态，皮肤环境特别容易发生溃疡复发。我们以前的研究表明，冷却这种皮肤可以减少异常的代谢活动，保护它免受溃疡复发。红外技术的最新进展使我们能够拍摄受影响皮肤的图像，以识别具有最高温度或脆弱的“热点”的区域。这些“热点”将自我监测的病人与新愈合的溃疡在家里与红外线温度计的日期和时间戳每个阅读。这项研究对身体活动的结果将使用加速度计进行评估。我们假设，通过改善皮肤环境和减轻疼痛，患者将更有可能进行身体活动，并有更好的生活质量，所有这些都是本研究的可测量目标。我们将在180名患者中评估这种预防策略，其中90名患者将随机接受冷却包，90名患者接受安慰剂。我们的目标是测试这种非药物，非侵入性的临床干预作为一种量身定制的自我管理策略，以防止慢性溃疡复发。它还将确定缓解症状，如疼痛，以及对体力活动和生活质量的衰弱影响。

 DESCRIPTION (provided by applicant): The goal of this randomized control trial is to test a patient directed self-monitoring and self-management intervention aimed at preventing the recurrence of chronic venous leg and diabetic foot ulcers using skin temperature and cryotherapy (cooling). We propose MUSTCOOL, a novel ulcer prevention strategy for patients at highest risk for developing chronic ulcers; those with a previous history. We aim to compare a cooling treatment to a placebo to determine the outcomes on ulcer recurrence, pain, physical activity and quality of life. Individuals with newly healed chronic ulcers will be invited to participate in MUSTCOOL's two component intervention: 1) self monitoring skin temperature over targeted "hot spots" daily with an infrared thermometer; and 2) maintenance cooling with a cooling pack (or placebo pack) placed over the "hot spot" three times each week for 30 minutes. If the temperature of the "hot spot" becomes elevated 2°F above baseline (average of 30 days of daily temperature readings) for 2 days in a row, a bolus regimen of 5 consecutive daily, 30 minute applications of the cooling or placebo pack will be implemented. We will monitor safety and side effects, however, there have been no reported adverse events reported in our previous cryotherapy studies. We designed this chronic ulcer prevention intervention that targets the remodeling phase, the final repair process of healing after chronic ulcer closure. The skin environment is particularly vulnerable to ulcer recurrence due to a persistent aberrant inflammatory state. Our previous research has demonstrated that cooling this skin reduces the abnormal metabolic activity, protecting it against ulcer recurrence. Recent advancements in infrared technology allow us to take images of the affect skin to identify the area that has the highest temperature or vulnerable "hot spot". These "hot spots" will be self monitored by patients with newly healed ulcers in the home with an infrared thermometer that date and time stamps each reading. The study's outcomes on physical activity will be evaluated with an accelerometer. We hypothesize that by improving the skin environment and reducing pain, patients will more likely be physically active and have better quality of life, all measurable goal for this study. We will evaluate this prevention strategy over six months in 180 patients, 90 of whom will be randomized to receive the cooling pack and 90 the placebo. Our goal is to test this non-pharmacological, non-invasive clinical intervention as a tailored self-management strategy to prevent chronic ulcer recurrence. It will also determine alleviation of symptoms such as pain, and the debilitating effects on physical activity and quality of life.