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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lymphedema

Intervention / Treatment
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* Device: Advanced Pneumatic Compression Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced Pneumatic Compression Group<br>All study participants will receive treatment using an advanced pneumatic compression device. | Device: Advanced Pneumatic Compression Device<br>* Advanced Pneumatic Compression Device<br>* Other names: Flexitouch Plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb circumference changes after 12 weeks and 52 weeks of treatment | 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 | 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 | 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 | 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 | Questionnaires to assess quality of life changes after 24 weeks of treatment | 24 weeks and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Swelling, Leg Lymphedema, Primary Lymphedema, Secondary Lymphedema