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

NCT01509599 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2016-04-05

No results posted yet for this study

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 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.

Conditions

  • Venous Disease
  • Venous Vascular Diseases and Syndromes
  • Venous Insufficiency
  • Venous Ulcers

Interventions

PROCEDURE

Cryotherapy: Cooling gel wrap

Patients will wear compression stockings (provided), elevate legs on an elevator pillow (provided) and apply the sham cyrotherapy: cooling gel wrap during the home-based intervention

PROCEDURE

Usual care

Patients will wear compression stockings (provided), elevate legs on an elevator pillow (provided) and apply the sham cyrotherapy wrap (sham) during the home-based intervention

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509599 on ClinicalTrials.gov