Assessment of quality of life and symptoms changes in primary or secondary, unilateral or bilateral lower extremity lymphedema patients using an advanced pneumatic compression system.
Post-market, on label, multi-center, single arm, observational clinical trial of a prospective cohort of 300 subjects with primary or secondary, unilateral or bilateral, lower extremity lymphedema in the United States. All subjects will receive pneumatic compression treatment for 52 weeks.
Study Type
OBSERVATIONAL
Enrollment
249
Advanced Pneumatic Compression Device
VA Maryland Healthcare System
Baltimore, Maryland, United States
VA New Jersey Health Care System (VANJHCS)
East Orange, New Jersey, United States
VA NY Harbor Healthcare System - Brooklyn
Brooklyn, New York, United States
VA Western New York Healthcare System
Buffalo, New York, United States
Quality of life changes: Questionnaires
Questionnaires to assess quality of life changes after 12 weeks of treatment
Time frame: 12 weeks
Lymphedema symptom changes
Questionnaires \[Lymphedema Quality of Life Tool (LYMQOL)\] to assess lymphedema. symptom changes after 12 weeks of treatment. LYMQOL includes sub-scores for Function (range 8-32), Appearance (range 7-28), Symptoms (range 5-20), and Mood (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.
Time frame: 12 weeks
Number of lymphedema and venous related healthcare visits
Comparison of the number of lymphedema and venous related health care visits the year preceding treatment and the during the 52 weeks while receiving treatment (or until study exit)
Time frame: 52 weeks
Limb circumference changes after 12 weeks and 52 weeks of treatment
Comparison of changes in limb circumference after 12 weeks and 52 weeks of treatment
Time frame: 12 weeks and 52 weeks
Fibrosis grading changes after 12 weeks and 52 weeks of treatment
Comparison of fibrosis grading (range Grade 0 to Grade 3, a lower grade represents a better outcome) after 12 weeks and 52 weeks of treatment
Time frame: 12 weeks and 52 weeks
Assessment of skin changes after 12 weeks and 52 weeks of treatment
Comparison of changes in the presence of skin conditions based on clinician observation after 12 weeks and 52 weeks of treatment
Time frame: 12 weeks and 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VA NY Harbor Healthcare System - St. Albans
Jamaica, New York, United States
VA NY Harbor Healthcare System - Manhattan
New York, New York, United States
Lymphedema staging changes after 12 weeks and 52 weeks of treatment
Comparison of lymphedema staging (range Grade 0 to Grade 3, a lower grade represents a better outcome) after 12 weeks and 52 weeks of treatment
Time frame: 12 weeks and 52 weeks
Quality of life changes: Questionnaires
Questionnaires to assess quality of life changes after 24 weeks of treatment
Time frame: 24 weeks and 52 weeks