Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Number of Participants With Ulcer Recurrence
研究概览
简要总结
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of cooling gel pack or placebo will be applied three times weekly to the affected skin, and a bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and quality of life will be measured.
详细描述
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). This MUSTCOOL study is a novel ulcer prevention strategy for patients at highest risk for developing chronic ulcers; those with a previous history. The aims are 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:
- self monitoring skin temperature over targeted "hot spots" daily with an infrared thermometer; and
- 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. The safety and side effects will be monitored, however, there have been no reported adverse events reported in our previous cryotherapy studies.
This study was designed as a 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. The previous research conducted by the study team 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. It is hypothesized that by improving the skin environment and reducing pain, patients will more likely be physically active and have better quality of life, all measurable goals for this study.
This prevention strategy will be evaluated over six months in 180 patients, 90 of whom will be randomized to receive the cooling pack and 90 the placebo. The 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly healed leg or diabetic foot ulcer within past 7 - 14 days
- •Ankle brachial index 0.8- 1.3mmHg (rule out absence of arterial disease)
- •Willing to wear compression stockings and appropriate footwear
- •Working freezer
排除标准
- •Open leg or foot ulcers
- •Cognitive impairment: unable to recall 2 or more words or draw clock Mini-Cog™ for cognitive impairment
- •Chronic inflammatory or vascular conditions where blood flow of skin may be impaired such as Lupus erythematosus, Raynaud's, scleroderma, end stage renal disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, on chemotherapy
- •Unable to preform required protocol activities without assistance (return demonstration to study staff)
结局指标
主要结局
Number of Participants With Ulcer Recurrence
时间窗: Through study completion at 6 months from baseline
Number of recurrent ulcers that develop during the 6 month study period for in participants for 4 groups of patients with previously healed venous leg ulcers receiving the cooling gel pack and cooling cotton pack and those with previously healed diabetic foot ulcers receiving the cooling gel pack or cooling cotton pack.
Differences in Step Counts
时间窗: Through study completion at 6 months from baseline
Differences in step counts reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.
Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire
时间窗: Through study completion at 6 months from baseline
The Venous Insufficiency Epidemiological and Economic Study-Quality of life/Symptoms (VEINES QOL/Sym) Questionnaire was used to evaluate quality of life. A sum score is provided as an overall quality of life score for both the QOL and Sym portions of the questionnaire. This instrument was used only for the VLU groups because it is a disease-specific measure. Of the 26 items in the questionnaire, 25 items are combined to create a summary score (VEINES-QOL). One item which asks about the time of day the leg problem is most intense, question 2, provides only descriptive information and is not scored. A subset (symptoms score) of ten of these items, questions 1a to 1i and 7, is used to create a symptom score (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym scores, high values indicate better outcomes. VEINES-QOL scores can be compared only to other members of the same sample. Each set of VEINES-QOL scores will have a mean T-score = 50.
Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire
时间窗: Through study completion at 6 months from baseline
Change in metabolic equivalent of task (METS) min per week for physical activity per The International Physical Activity Questionnaire reported for 4 groups from baseline to 6 months end of study. Scoring HIGH indicate physical activity levels equate to \~1hour of activity per day or more at least moderate intensity level or engage in vigorous intensity activity on at least 3 days achieving a minimum total physical activity of at least 1500 MET min a week or 7 or more days of any combination of walking, moderate intensity or vigorous intensity activities achieving a minimum total physical activity of at least 3000 MET min a week. MODERATE suggests engagement equivalent to 30 min of at least moderate intensity activity on most days; engage in 3 or more days of vigorous intensity activity and/or walking of at least 30 min per day or 5 or more days of moderate intensity activity and/or walking of at least 30 minutes per day. LOW level means that neither MODERATE or HIGH levels are met.
Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory
时间窗: Through study completion at 6 months from baseline
The Brief Pain Inventory (BPI) scale is reported as an average score. BPI rapidly assesses the severity of pain and its impact on functioning for intensity and Pain Intensity and Pain Interference. Pain Intensity is measured in four categories: worst, least, on average, and currently, while Pain Interference is measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10, 10 being excruciating pain intensity and a complete interference in their life. Subscores are determined by averaging over the 4 intensity items for the severity subscore and over the 7 interference items for the interference subscore; possible total scores range from 0 to 10. Higher scores indicate worse intensity and severity.
Change in Pain (Worst Pain, Least Pain, Pain Now)
时间窗: Through study completion at 6 months from baseline
Pain was measured with a visual analog scale and reported numerically (0 to 10 with 10 being the most severe pain) at baseline and at 6 months end of study
Time Spent in Minutes Engaging in Physical Activities
时间窗: Through study completion at 6 months from baseline
Mean time spent in minutes engaging in physical activities, reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.
次要结局
- Knowledge Questionnaire of Study Instructions(Baseline after participant enrollment)
- Participant Adherence to the Study Protocol(Daily measures starting at baseline for temperature and every other day cooling application during the 6-month study period.)
- Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness(Survey conducted at end of the 6-month study period.)