Cryotherapy for Chronic Venous Disorders: A Pilot Study

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DESCRIPTION (provided by applicant): Chronic venous disorders (CVD) often cause long-term disability for those who experience the worst manifestations of CVD: disabling pain and non-healing leg ulcers. Such disabilities have significant socioeconomic implications in terms of lost work days and wages, decreased productivity, and ultimately increased health cares costs that deteriorate the well-being and quality of life for those who have CVD-induced illnesses. Because no reliable preventive mechanism exists for CVD, this study proposes a preventive, self management cryotherapy intervention that targets inflamed skin of populations with CVD at highest risk of developing chronic leg ulcers. The proposed cryotherapy intervention will utilize a randomized controlled clinical trial to develop a method to reduce clinical symptoms by improving existing therapy-it is not a treatment for CVD itself. In the proposed pilot feasibility study, subjects will be randomized to two groups: the cryotherapy intervention group (n=30) who will receive a four-week, cryotherapy gel wrap applied daily to affected skin of the lower legs in addition to the standard of care (usual care). The control group (n=30) will receive the usual care of compression wraps or stockings applied to the lower legs and daily leg elevation. With this method, improvement of skin microcirculation, reduced leg pain, and improvement in quality of life will be observed. The following aims will test the hypothesis: Aim 1. Evaluate the feasibility of the novel intervention including treatment fidelity, subject training, safety, and side effects associated with equipment and recruitment efforts and further refine the intervention protocol, including questionnaires used in our previous studies. Aim 2. Estimate variability of outcome measurements and effect sizes needed to calculate sample size for a subsequent larger, adequately powered, randomized clinical trial of the efficacy of the novel cryotherapy intervention. Aim 3. Investigate the presence of a preliminary "signal" of clinical efficacy of the experimental treatment by evaluating trends toward statistical significance for the hypothesis that the experimental group will experience greater reduction in skin temperature and blood flow, greater improvement in pain, and greater improvement in quality of life. It is predicted that this novel cryotherapy model and method will significantly improve the health and quality of life for those with CVD and related disorders, and that the intervention will become the standard of care for CVD. In addition, the method will, over time, reduce health care costs associated with treating poor CVD outcomes.