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 30, 2021
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Condition or disease | Intervention/treatment |
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Lymphedema | Device: Advanced Pneumatic Compression Device |
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 2021 |
Estimated Study Completion Date : | December 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Advanced Pneumatic Compression Group
All study participants will receive treatment using an advanced pneumatic compression device.
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Device: Advanced Pneumatic Compression Device
Advanced Pneumatic Compression Device
Other Names:
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- Quality of life changes: Questionnaires [ Time Frame: 12 weeks ]Questionnaires to assess quality of life changes after 12 weeks of treatment
- 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.
- 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)
- 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
- 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
- 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
- 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
- Quality of life changes: Questionnaires [ Time Frame: 24 weeks and 52 weeks ]Questionnaires to assess quality of life changes after 24 weeks of treatment

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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 |
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.
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.

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
Contact: Susy Peters | speters@tactilemedical.com | ||
Contact: Alexa Bennett | abennett@tactilemedical.com |
United States, Connecticut | |
VA Connecticut Healthcare System - West Haven | Recruiting |
West Haven, Connecticut, United States, 06516 | |
Contact: Patty Fugal, MS 203-785-4855 patricia.fugal@yale.edu | |
Principal Investigator: Naiem Nassiri, MD | |
United States, Maryland | |
VA Maryland Healthcare System | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Rachel White 410-605-7000 ext 55677 rcwhite@som.umaryland.edu | |
Principal Investigator: Areck Ucuzian, MD, PhD | |
Sub-Investigator: Brajesh Lal, MD | |
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 | |
Contact: Brianna Bisogno Brianna.Bisogno@va.gov | |
Principal Investigator: Thomas Maldonado, MD | |
VA Western New York Healthcare System | Recruiting |
Buffalo, New York, United States, 14215 | |
Contact: Ann Galla 716-860-6653 ann.galla@va.gov | |
Principal Investigator: Hasan H Dosluoglu, MD | |
Sub-Investigator: Mariel Rivero, MD | |
VA NY Harbor Healthcare System - St. Albans | Completed |
Jamaica, New York, United States, 11425 | |
VA NY Harbor Healthcare System - Manhattan | Recruiting |
New York, New York, United States, 10010 | |
Contact: Loretta Hadjioannou Loretta.Hadjioannou@va.gov | |
Principal Investigator: Thomas Maldonado, MD |
Principal Investigator: | Thomas Maldonado, MD | NYU |
Responsible Party: | Tactile Medical |
ClinicalTrials.gov Identifier: | NCT02661646 |
Other Study ID Numbers: |
5010 |
First Posted: | January 22, 2016 Key Record Dates |
Last Update Posted: | March 30, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Chronic Swelling Leg Lymphedema Primary Lymphedema Secondary Lymphedema |
Lymphedema Lymphatic Diseases |