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

NCT02661646 | Terminated

• 1 other identifier: 5010
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Lymphedema

Keywords

Chronic Swelling; Leg Lymphedema; Primary Lymphedema; Secondary Lymphedema

Outcome Measures

Primary Outcomes (3)

• Quality of life changes: Questionnaires

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

  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.

  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)

  52 weeks

Secondary Outcomes (5)

• Limb circumference changes after 12 weeks and 52 weeks of treatment

  12 weeks and 52 weeks

• Fibrosis grading changes 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

  12 weeks and 52 weeks

• Lymphedema staging changes after 12 weeks and 52 weeks of treatment

  12 weeks and 52 weeks

• Quality of life changes: Questionnaires

  24 weeks and 52 weeks

Study Arms (1)

Advanced Pneumatic Compression Group

All study participants will receive treatment using an advanced pneumatic compression device.

Device: Advanced Pneumatic Compression Device

Interventions

Advanced Pneumatic Compression Device DEVICE

Advanced Pneumatic Compression Device

Also known as: Flexitouch system, Flexitouch Plus

Advanced Pneumatic Compression Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tactile Medical: lead

Study Sites (6)

VA Maryland Healthcare System

Baltimore, Maryland, 21201, United States

Location

VA New Jersey Health Care System (VANJHCS)

East Orange, New Jersey, 07018, United States

Location

VA NY Harbor Healthcare System - Brooklyn

Brooklyn, New York, 11209, United States

Location

VA Western New York Healthcare System

Buffalo, New York, 14215, United States

Location

VA NY Harbor Healthcare System - St. Albans

Jamaica, New York, 11425, United States

Location

VA NY Harbor Healthcare System - Manhattan

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Thomas Maldonado, MD

  NYU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 22, 2016
• Study Start: December 1, 2015
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)