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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Venous Disease, Venous Vascular Diseases and Syndromes, Venous Insufficiency, Venous Ulcers

In brief

Leg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, boot-like gel wrap placed around the damaged skin of the lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression stockings) intervention compared to a low compression non-cryotherapy "sham" wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5 venous insufficiency.

Key facts

Study ID

NCT01509599

Run by

Medical University of South Carolina

People needed

197

Starts

2011-08-01

Expected to finish

2015-12-01

Last updated by the study team

2016-04-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States

Full record on ClinicalTrials.gov

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