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Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence (MUSTCOOL)

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ClinicalTrials.gov Identifier: NCT02626156
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
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.

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

Detailed Description:

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:

  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. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Ulcer incidence [ Time Frame: 6 months ]
    The development of a recurrent ulcer will be tracked and recorded on study logs.

  2. 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).

  3. 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.

  4. 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.

  5. Pain [ Time Frame: 6 months ]
    The Brief Pain Inventory scale and reported as a sum score.

  6. Physical activity [ Time Frame: 6 months ]
    Data from The International Physical Activity Questionnaire will be analyzed to report an overall physical activity score.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Teresa Kelechi, PhD 843-792-4602 kelechtj@musc.edu
Contact: Margie Prentice, MBA 843-792-4771 prenticm@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29412
Contact: Margie Prentice, MBA    843-792-4771    prenticm@musc.edu   
Contact: Teresa Kelechi, PhD    843-792-4602    kelechtj@musc.edu   
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Darla Howard, BSN    864-560-1042    dhoward@srhs.com   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Study Director: Moby Madisetti, MS Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02626156     History of Changes
Other Study ID Numbers: Pro00043450
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

Keywords provided by Medical University of South Carolina:
post healed venous leg ulcer
posted healed diabetic foot ulcer

Additional relevant MeSH terms:
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Ulcer
Recurrence
Diabetic Foot
Foot Ulcer
Leg Ulcer
Venous Insufficiency
Varicose Ulcer
Pathologic Processes
Disease Attributes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Varicose Veins
Methyl salicylate
Antirheumatic Agents