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

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ClinicalTrials.gov Identifier: NCT02661646
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tactile Medical

Study Description
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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.

Condition or disease Intervention/treatment
Lymphedema Device: Advanced Pneumatic Compression Device

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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life changes: Questionnaires [ Time Frame: 12 weeks ]
    Questionnaires to assess quality of life changes after 12 weeks of treatment

  2. 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.

  3. Lymphedema and venous related complication rate changes [ Time Frame: 52 weeks ]
    Comparison of the lymphedema and venous related complication rates in the year preceding treatment and the during the 52 weeks while receiving treatment

  4. Lymphedema and venous related unscheduled visit rate changes [ Time Frame: 52 weeks ]
    Comparison of the lymphedema and venous related unscheduled visit rates in the year preceding treatment and the during the 52 weeks while receiving treatment


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Quality of life changes: Questionnaires [ Time Frame: 24 weeks ]
    Questionnaires to assess quality of life changes after 24 weeks of treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661646


Contacts
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Contact: Jill Christensen jchristensen@tactilemedical.com
Contact: Suzanne Hansel shansel@tactilemedical.com

Locations
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United States, New Jersey
VA New Jersey Health Care System (VANJHCS) Recruiting
East Orange, New Jersey, United States, 07018
Contact: Frank Padberg, MD    973-676-1000 ext 1208    frank.padberg@va.gov   
Contact: Celeste DeMarco, APN-C    (973) 676-1000 ext 11898    celeste.demarco@va.gov   
Principal Investigator: Frank Padberg, MD         
United States, New York
VA NY Harbor Healthcare System - Brooklyn Recruiting
Brooklyn, New York, United States, 11209
Principal Investigator: Thomas Maldonado, MD         
VA NY Harbor Healthcare System - St. Albans Recruiting
Jamaica, New York, United States, 11425
Principal Investigator: Thomas Maldonado, MD         
VA NY Harbor Healthcare System - Manhattan Recruiting
New York, New York, United States, 10010
Principal Investigator: Thomas Maldonado, MD         
Sponsors and Collaborators
Tactile Medical
Investigators
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Principal Investigator: Thomas Maldonado, MD NYU
More Information
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Responsible Party: Tactile Medical
ClinicalTrials.gov Identifier: NCT02661646     History of Changes
Other Study ID Numbers: 5010
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tactile Medical:
Chronic Swelling
Leg Lymphedema
Primary Lymphedema
Secondary Lymphedema
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases