Status:
COMPLETED
Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Venous Disease
Venous Vascular Diseases and Syndromes
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 p...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT01509599
Start Date
August 1 2011
End Date
December 1 2015
Last Update
April 5 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
2
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303