Lymphedema
Conditions
Keywords
Chronic Swelling, Leg Lymphedema, Primary Lymphedema, Secondary Lymphedema
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.
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.
Interventions
DEVICEAdvanced Pneumatic Compression Device
Advanced Pneumatic Compression Device
Sponsors
Tactile Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life changes: Questionnaires | 12 weeks | Questionnaires to assess quality of life changes after 12 weeks of treatment |
| Lymphedema symptom changes | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymphedema staging changes after 12 weeks and 52 weeks of treatment | 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 |
| Limb circumference changes after 12 weeks and 52 weeks of treatment | 12 weeks and 52 weeks | Comparison of changes in limb circumference after 12 weeks and 52 weeks of treatment |
| Quality of life changes: Questionnaires | 24 weeks and 52 weeks | Questionnaires to assess quality of life changes after 24 weeks of treatment |
| Fibrosis grading changes after 12 weeks and 52 weeks of treatment | 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 | 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 |
Countries
United States
Outcome results
None listed