Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation

This new trial will assess the efficacy of this home-based cryotherapy intervention by
adding sequenced tapered cooling after a 30-day intense cooling period. The goal is to
reduce skin blood flow of chronically inflamed skin, decrease the incidence of venous leg
ulcers and pain, and improve quality of life. A myriad of surgical, pharmacologic, and
non-pharmacologic therapies such as compression bandages are often tried, many with limited
success. More than 70% of patients with venous disorders such as insufficiency develop
edema, skin damage, and ulcers. Ulcer prevention is warranted because of the significant
socioeconomic implications in terms of lost workdays and wages, decreased productivity and
increased health care costs. Clinicians focus on the multiple treatment approaches, often
without consideration of how patients can contribute to their own self-care. Our 9-month
intervention is based on principles of heat transfer and cryotherapy theories involving
microcirculation. With input from a cryotherapy expert and participants who completed the
R21 pilot, the investigators propose a sequenced intervention strategy, where cooling will
be dosed daily for 30 minutes for the first month, and then decreased to twice weekly dosing
in months 2-3, once weekly in months 4-6, then PRN in months 7-9. The investigators will
measure blood flow, skin temperature, pain, quality of life, and the incidence of leg ulcers
after months 1, 3, 6 and 9. Eligible participants will be randomized to treatment (low
compression cooling wrap) or usual care (low compression non-cooling "sham" wrap).
Participants in both groups will receive all study related materials including standardized
instruction, skin thermometer, specially designed low compression wraps, leg elevator
pillow, and compression stockings, and during an in-depth orientation session. The
investigators hypothesize that cryotherapy will enhance the largely ineffective
non-pharmacologic self-care usual care model, that is, telling patients to wear compression
stockings, elevate the legs, and get more exercise. These strategies are generally
inadequate in achieving sustained change. Among our research methods the investigators
include rigorous process, impact and outcome monitoring. In an era of expectation for
technological and pharmaceutical "fixes", this self-care strategy, if efficacious, could be
an economical way to decrease morbidity and pain for thousands of patients, frequently
viewed as non-responsive to self care. Prevention of ulcers is also a major potential source
of saved medical dollars. This trial is significant due to the burden of venous disorders,
the complex physical characteristics of the population including excessive obesity and
co-morbidity and the need to reach patients with a feasible, motivational, and supportive
strategy to promote self-care. The objective is to establish a new practice standard for
prevention.

Inclusion Criteria:

- aged 21 years or older

- CEAP Classification: Stage C4 (skin damage) and 5 (healed VLU) - leg ulcer healed
within past month with intact epithelium

- history of healed VLU within past 2 years

- ankle brachial index (ABI) 0.80 - 1.3 mmHG, absence of peripheral arterial disease

- intact skin sensation

- intact thermal sensation

- agreement to ear compression during waking hours

- phone, email or mail accessible

- willingness to make 5 study visits including baseline

- able to understand protocol by passing test after watching DVD standardized
instructions for low literacy

- able to perform required protocol activities

- ability to speak English

Exclusion Criteria:

- diagnosed arterial disease or ABI <0.80 or >1.3 mm Hg (blood flow to the skin is
reduced in arterial disease and cooling could cause tissue ischemia)

- surgical procedures on leg in past 1 year (can affect venous circulation/cause edema)

- open leg/foot ulcers

- recent leg infection within past month (increased inflammation)

- impaired cognitive status (cannot perform procedures)

- chronic inflammatory and vascular conditions where blood flow of the skin may be
impacted such as Lupus erythematosus, lymphedema, Raynaud's, rheumatoid arthritis,
scleroderma, end stage renal disease, chronic obstructive pulmonary disease, chronic
regional pain syndrome, multiple sclerosis, hypersensitivity to cold, or patients on
chemotherapy