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

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Venous Hypertension Ulcers; Diabetic Foot; Foot Ulcer; Varicose Ulcer; Venous Ulcer; Venous Insufficiency; Venous Stasis Ulcer; Leg Ulcer

Treatments: Device: Cooling gel pack; Device: Cooling cotton pack

Study type: Interventional

Funder types: Other

Identifiers

NCT02626156

Pro00043450

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Cooling gel pack

Experimental group

Description:

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.

Treatment:

Device: Cooling gel pack

Cooling cotton pack

Active Comparator group

Description:

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.

Treatment:

Device: Cooling cotton pack