Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD)

March 29, 2023 updated by: Tactile Medical

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • VA Maryland Healthcare System
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • VA New Jersey Health Care System (VANJHCS)
    • New York
      • Brooklyn, New York, United States, 11209
        • VA NY Harbor Healthcare System - Brooklyn
      • Buffalo, New York, United States, 14215
        • VA Western New York Healthcare System
      • Jamaica, New York, United States, 11425
        • VA NY Harbor Healthcare System - St. Albans
      • New York, New York, United States, 10010
        • VA NY Harbor Healthcare System - Manhattan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary or secondary, unilateral or bilateral, lower extremity lymphedema patients using the Flexitouch system during a 52 week study period.

*Note: Only Veteran's are eligible as this study is run through The Department of Veterans Affairs New York Harbor Healthcare System.

Description

Inclusion Criteria:

  • Age 18 or older
  • Diagnosis of primary or secondary, unilateral or bilateral, lower extremity lymphedema
  • Ability and willingness to participate in all aspects of the study including following prescribed care
  • Ability to provide informed consent
  • Must have a prescription for the Flexitouch (Flexitouch system or Flexitouch Plus)

Exclusion Criteria:

  • Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer.
  • Active skin or limb infection/inflammatory disease (acute cellulitis, or other uncontrolled skin or untreated inflammatory skin disease)
  • Acute thrombophlebitis (in last 2 months)
  • Pulmonary embolism within the previous 6 months
  • Deep Vein Thrombosis (DVT) within the previous 3 months
  • Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)
  • Pulmonary edema
  • Heart failure (acute pulmonary edema, decompensated acute heart failure)
  • Patients with poorly controlled asthma
  • Previous use of the study pneumatic compression device (PCD)
  • Currently using multi-layer bandaging (MLB) unless bandages can be removed for limb circumference measurements
  • Pregnant women or women of childbearing potential not on contraception
  • Any condition where increased venous and lymphatic return is undesirable
  • Currently participating in another medical device or drug clinical trial
  • Signs of noncompliance at the week 4 visit including: using the device less than 3 times per week and/or not attending the scheduled visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Advanced Pneumatic Compression Group
All study participants will receive treatment using an advanced pneumatic compression device.
Device: Advanced Pneumatic Compression Device
Advanced Pneumatic Compression Device
Other Names:
  • Flexitouch system
  • Flexitouch Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life changes: Questionnaires
Time Frame: 12 weeks
Questionnaires to assess quality of life changes after 12 weeks of treatment
12 weeks
Lymphedema symptom changes
Time Frame: 12 weeks
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.
12 weeks
Number of lymphedema and venous related healthcare visits
Time Frame: 52 weeks
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)
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb circumference changes after 12 weeks and 52 weeks of treatment
Time Frame: 12 weeks and 52 weeks
Comparison of changes in limb circumference after 12 weeks and 52 weeks of treatment
12 weeks and 52 weeks
Fibrosis grading changes after 12 weeks and 52 weeks of treatment
Time Frame: 12 weeks and 52 weeks
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
12 weeks and 52 weeks
Assessment of skin changes after 12 weeks and 52 weeks of treatment
Time Frame: 12 weeks and 52 weeks
Comparison of changes in the presence of skin conditions based on clinician observation after 12 weeks and 52 weeks of treatment
12 weeks and 52 weeks
Lymphedema staging changes after 12 weeks and 52 weeks of treatment
Time Frame: 12 weeks and 52 weeks
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
12 weeks and 52 weeks
Quality of life changes: Questionnaires
Time Frame: 24 weeks and 52 weeks
Questionnaires to assess quality of life changes after 24 weeks of treatment
24 weeks and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tactile Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5010 (the 5010 Foundation of Sun Yat-sen University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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