Clinical trial NCT02626156: Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
Official title: Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Hypertension Ulcers
Venous Stasis Ulcer
Venous Ulcer
Venous Insufficiency
Leg Ulcer
Foot Ulcer
Varicose Ulcer
Diabetic Foot
Keywords: post healed venous leg ulcer
posted healed diabetic foot ulcer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Number of Participants With Ulcer Recurrence
timeFrame: Through study completion at 6 months from baseline
measure: Change in Pain (Worst Pain, Least Pain, Pain Now)
timeFrame: Through study completion at 6 months from baseline
measure: Differences in Step Counts
timeFrame: Through study completion at 6 months from baseline
measure: Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire
timeFrame: Through study completion at 6 months from baseline
measure: Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory
timeFrame: Through study completion at 6 months from baseline
measure: Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire
timeFrame: Through study completion at 6 months from baseline
measure: Time Spent in Minutes Engaging in Physical Activities
timeFrame: Through study completion at 6 months from baseline
Secondary outcomes:
measure: Participant Adherence to the Study Protocol
timeFrame: Daily measures starting at baseline for temperature and every other day cooling application during the 6-month study period.
measure: Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness
timeFrame: Survey conducted at end of the 6-month study period.
measure: Knowledge Questionnaire of Study Instructions
timeFrame: Baseline after participant enrollment
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Moby Madisetti, MS
role: STUDY_DIRECTOR
References:
citation: Kelechi TJ, Mueller M, Madisetti M, Prentice M. Efficacy of a Self-managed Cooling Intervention for Pain and Physical Activity in Individuals With Recently Healed Chronic Venous Leg and Diabetic Foot Ulcers: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2022 Jul-Aug 01;49(4):365-372. doi: 10.1097/WON.0000000000000880. Epub 2022 May 4.
citation: Kelechi TJ, Madisetti M, Prentice M, Mueller M. Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2021 May-Jun 01;48(3):203-210. doi: 10.1097/WON.0000000000000753.