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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings