Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence (MUSTCOOL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02626156|
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Venous Hypertension Ulcers Venous Stasis Ulcer Venous Ulcer Venous Insufficiency Leg Ulcer Foot Ulcer Varicose Ulcer Diabetic Foot||Device: Cooling gel pack Device: Cooling cotton pack||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Cooling gel pack
A cooling pack will be applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients will self monitor skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline.
Device: Cooling gel pack
Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cooling gel pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.
Active Comparator: Cooling cotton pack
A cooling cotton pack will be applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients will self monitor skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline.
Device: Cooling cotton pack
Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cotton filled pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.
- Ulcer incidence [ Time Frame: 6 months ]The development of a recurrent ulcer will be tracked and recorded on study logs.
- Pain [ Time Frame: 6 months ]Pain will be measured with a visual analog scale and reported numerically (0 to 10 with 10 being the most severe pain).
- Physical activity [ Time Frame: 6 months ]An accelerometer will will worn by patients to monitor physical activity and data will be reported in frequency of activities, time spent, and steps.
- Quality of life [ Time Frame: 6 months ]The VEINES QOL/Sym Questionnaire will be used to evaluate quality of life. A sum score will provide data for an overall quality of life score.
- Pain [ Time Frame: 6 months ]The Brief Pain Inventory scale and reported as a sum score.
- Physical activity [ Time Frame: 6 months ]Data from The International Physical Activity Questionnaire will be analyzed to report an overall physical activity score.
- Asess appropriate use of thermometer and cooling pack application [ Time Frame: 6 months ]Using data logs upon which to record data, the following questions will be asked: What was adherence to the protocol by the participants? What were the challenges and problems to adherence regarding use of the thermometer to self monitor skin temperature and application of the cooling pack to the skin? Check boxes for missed applications and reasons for lapses will be included.
- Reinforcement and participant reactions [ Time Frame: 6 months ]Retention telephone, email and in-person reinforcement logs will be used to record data regarding side effects, tolerability, comfort, concerns about the study, or problems with the disease process.
- Staff observation [ Time Frame: 6 months ]Using rating logs, 10% of participant education sessions and study visits will be observed to monitor fidelity to participant visit protocols. Interviews of staff will be conducted each month to elicit feedback on issues with participant identification and recruitment issues, reach, enrollment procedures and other study protocol issues that may arise.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626156
|Contact: Teresa Kelechi, PhDfirstname.lastname@example.org|
|Contact: Margie Prentice, MBAemail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29412|
|Contact: Margie Prentice, MBA 843-792-4771 firstname.lastname@example.org|
|Contact: Teresa Kelechi, PhD 843-792-4602 email@example.com|
|Spartanburg Regional Medical Center||Recruiting|
|Spartanburg, South Carolina, United States, 29303|
|Contact: Darla Howard, BSN 864-560-1042 firstname.lastname@example.org|
|Study Director:||Moby Madisetti, MS||Medical University of South Carolina|