冷却干预（MUSTCOOL）预防下肢溃疡复发：一项随机对照试验。
Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial.
机构信息
Teresa J. Kelechi, PhD, College of Nursing, Medical University of South Carolina, Charleston.
Mohan Madisetti, MS, Medical University of South Carolina, Charleston.
出版信息
J Wound Ostomy Continence Nurs. 2021;48(3):203-210. doi: 10.1097/WON.0000000000000753.
PURPOSE
The purpose of this study was to test our MUSTCOOL cooling patch intervention on the incidence of venous leg (VLU) and diabetic foot ulcer (DFU) recurrence over a previously healed wound.
DESIGN
A 6-month randomized controlled trial.
SUBJECTS AND SETTING
The target population was individuals with previously healed ulcers receiving care in outpatient wound centers in the Southeastern region of the United States. The sample comprised 140 individuals with recently healed ulcers; their average age was 62.4 years (SD = 12 years); 86 (61.4%) were male; and 47 (33.6%) were Black or African American.
METHODS
Participants were randomized to the MUSTCOOL or placebo patch. Both groups received instructions to apply the patch 3 times per week, and engage in standard of care including compression and leg elevation (VLU) or therapeutic footwear and hygiene (DFU). Demographic data were collected at baseline, and incidence measures taken at 1, 3, and 6 months. We also studied whether new ulcers developed on the adjacent leg or foot. Data were reported in frequencies/percentages.
RESULTS
One hundred seventeen participants (84%) were analyzed who completed 6 months of study participation. Thirteen percent (9/69) and 17% (12/69) developed a recurrent or new VLU, respectively; 29% (14/48) and 13% (6/48) developed a recurrent or new DFU, respectively. One person in the DFU group developed both a recurrent and new ulcer. For 9 recurrent VLUs, 6 (66.7%) recurred in the MUSTCOOL group and 3 (33.3%) receiving the placebo. Of the 15 recurrent DFUs (includes individual who developed both a recurrent and new ulcer), 10 (66.7%) recurred in the MUSTCOOL group and 5 (33.3%) receiving the placebo.
CONCLUSIONS
While the incidence of ulcer recurrent was slightly higher in the MUSTCOOL group, this finding was not considered clinically relevant. Overall ulcer recurrence during the 6-month study period was lower than reports in the literature, the time frame in which recurrence rates are highest.
TRIAL REGISTRATION
The study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156)-https://clinicaltrials.gov/ct2/show/NCT02626156.
目的
本研究旨在测试 MUSTCOOL 冷却贴片干预对先前愈合伤口处静脉腿部（VLU）和糖尿病足溃疡（DFU）复发的影响。
设计
一项为期 6 个月的随机对照试验。
研究对象和场所
目标人群为在美东南地区门诊伤口中心接受治疗的、有过愈合溃疡的个体。该样本由 140 名近期愈合溃疡的个体组成；他们的平均年龄为 62.4 岁（SD=12 岁）；86 名（61.4%）为男性；47 名（33.6%）为黑种人或非裔美国人。
方法
参与者被随机分配到 MUSTCOOL 或安慰剂贴片组。两组均被指示每周使用贴片 3 次，并接受标准护理，包括压迫和腿部抬高（VLU）或治疗性鞋具和卫生（DFU）。在基线时收集人口统计学数据，并在 1、3 和 6 个月时进行发病情况测量。我们还研究了新溃疡是否在相邻腿部或脚部出现。数据以频率/百分比报告。
结果
117 名参与者（84%）完成了 6 个月的研究参与，对其进行了分析。分别有 13%（9/69）和 17%（12/69）发生了复发性或新的 VLU；29%（14/48）和 13%（6/48）发生了复发性或新的 DFU。DFU 组中有 1 人同时出现了复发性和新溃疡。在 9 例复发性 VLU 中，MUSTCOOL 组中有 6 例（66.7%）复发，安慰剂组中有 3 例（33.3%）复发。在 15 例复发性 DFU 中（包括同时出现复发性和新溃疡的个体），MUSTCOOL 组中有 10 例（66.7%）复发，安慰剂组中有 5 例（33.3%）复发。
结论
尽管 MUSTCOOL 组的溃疡复发发生率略高，但这一发现并不被认为具有临床意义。在 6 个月的研究期间，总体溃疡复发率低于文献报告的最高复发率时间段。
试验注册
该研究于 2015 年 12 月 10 日在 ClinicalTrials.gov 上进行了前瞻性注册（标识符：NCT02626156）-https://clinicaltrials.gov/ct2/show/NCT02626156。
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