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

 描述(申请人提供)：这项随机对照试验的目标是测试一种患者指导的自我监测和自我管理干预措施，旨在使用皮肤温度和冷冻(降温)预防慢性静脉性小腿和糖尿病足部溃疡的复发。我们提出了MUSTCOOL，这是一种新的溃疡预防策略，适用于有慢性溃疡高危患者；有既往病史的患者。我们的目标是将降温治疗与安慰剂进行比较，以确定在溃疡复发、疼痛、体力活动和生活质量方面的结果。新治愈的慢性溃疡患者将被邀请参加MUSTCOOL的两个组成部分的干预：1)使用红外温度计每天自我监测目标“热点”上的皮肤温度；2)每周三次在“热点”上放置冷却包(或安慰剂包)进行持续降温，持续30分钟。如果“热点”的温度连续两天高于基线2°F(平均每天30天的温度读数)，将实施连续5天、30分钟的降温或安慰剂包给药方案。我们将监测安全性和副作用，然而，在我们之前的冷冻治疗研究中没有报道过不良事件。我们设计了这一慢性溃疡预防干预措施，目标是慢性溃疡愈合后的重塑阶段，即最终修复过程。由于持续的异常炎症状态，皮肤环境特别容易出现溃疡复发。我们之前的研究已经证明，给皮肤降温可以减少异常代谢活动，防止溃疡复发。红外线技术的最新进展使我们能够拍摄受影响皮肤的图像，以识别温度最高或易受攻击的“热点”区域。这些“热点”将由家中新治愈的溃疡患者用红外温度计进行自我监测，红外线温度计可以在每个读数上标出日期和时间。这项研究的体力活动结果将通过加速计进行评估。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，并拥有更好的生活质量，这些都是本研究的可衡量目标。我们将在六个月内对180名患者评估这一预防策略，其中90人将随机接受冷冻袋治疗，90人接受安慰剂治疗。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。它还将决定疼痛等症状的缓解，以及对身体活动和生活质量的削弱效果。

 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.