Feasibility Study of Cryotherapy for Chronic Venous Disorders

Completed · Not applicable

Conditions studied: Venous Insufficiency

In brief

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.

Key facts

Study ID

NCT00617825

Run by

Medical University of South Carolina

People needed

60

Starts

2007-09-01

Expected to finish

2009-08-01

Last updated by the study team

2018-06-15

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 45 years and older
• CEAP classification: stage C4 (changes in skin and subcutaneous tissue secondary to CVDs)4a (pigmentation or eczema) 4b (lipodermatosclerosis or atrophie blanche) C5 (healed venous ulcers)
• Ankle brachial index (ABI) 0.9 - 1.3mm Hg 0 absence of peripheral arterial disease
• Intact skin sensation measured with 10 gram monofilament
• Intact thermal sensation measured with thermal sensory tester at lower leg skin and foot surfaces
• Agreement to wear compression garments such as wraps or stockings during waking hours
• Phone, e-mail, or mail accessible
• Working freezer

You may not qualify if…

• ABI < 0.8 mm Hg or > 1.3 mm Hg -presence of lower extremity arterial disease (reduces skin temperature)
• Active systemic or localized infections such as cellulitis (raises skin temperature)
• Autoimmune disorders that reduce blood flow such as Raynaud's phenomenon
• Body temperature > 37.6 degrees C (febrile state raises skin temperature)
• CEAP classification c6: active venous ulcer (cooling ulcerated skin might impair healing)
• Known peroneal nerve injury
• Impaired skin sensation
• Unable to detect light touch measured with a 10 gram monofilament at lower leg skin surfaces
• Unable to detect not/cold sensation measured with thermal sensory tester at lower leg skin surfaces
• Not wearing compression or not agreeing to wear compression wraps or stockings
• Phone, e-mail, or mail inaccessible
• No working freezer

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.