Clinical Trial: Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced PCD

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home

Brief Summary: Assessment of QOL and symptoms changes in primary or secondary, unilateral or bilateral lower extremity patients using an advanced pneumatic compression system.

Detailed Summary: Multi-centered, single arm, observational clinical trial of a prospective cohort of an estimated 300 participants with primary or secondary, unilateral or bilateral, lower extremity lymphedema. All participants receive intermittent pneumatic compression treatment for 52 weeks. Quality of life and symptoms will be assessed pre- and post - intermittent pneumatic compression treatment at 12, 24 and 52 weeks.
Sponsor: Tactile Medical

Current Primary Outcome: Quality of life [ Time Frame: 12 weeks ]

Questionnaires to assess quality of life changes after 12 weeks of treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tactile Medical

Dates:
Date Received: January 18, 2016
Date Started: December 2015
Date Completion: December 2019
Last Updated: April 26, 2017
Last Verified: April 2017