NCT00617825

Feasibility Study of Cryotherapy for Chronic Venous Disorders

Cryotherapy for Chronic Venous Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized and under-treated disorders shat harm the veins of the legs and at worst, cause skin inflammation and venous leg ulcers. A new way to ease the pain and inflammation is proposed in this study of cryotherapy (cool gel wraps) applied to damaged skin of the lower legs of CVD-affected individuals. The study hypothesis predicts that this novel cryotherapy model and method will significantly improve the health and quality of life for those with CVDs and that the intervention will become a standard of care for CVDs. In addition, the method will, over time, reduce health care costs associated with treating poor CVD outcomes.

Detailed description

Chronic venous disorders (CVDs) often cause long-term disability for those who experience the worst manifestations of CVDs: 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 care costs that deteriorate the well-being and quality of life for those who have CVD-induced illnesses. Because no reliable preventive mechanisms exists for CVDs, this study proposes a preventive, self-management cryotherapy intervention that targets inflamed skin of populations with CVDs 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 CVDs 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 the 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.

Conditions

• Venous Insufficiency

Interventions

Type	Name	Description
OTHER	cyrotherapy as a cool gel wrap	A cool gel wrap made of a hydrogel with silicon will be applied to the lower leg of skin affected by venous disorders for 30 minutes each day for 30 days during the study

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2008-02-18
• Last updated: 2018-06-15

Locations

1 site across 1 country: United States