Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence

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.

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)