Clinical trial NCT02661646: Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD)
Official title: Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lymphedema
Keywords: Chronic Swelling
Leg Lymphedema
Primary Lymphedema
Secondary Lymphedema
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
First posted: 2016-01-22
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Quality of life changes: Questionnaires
timeFrame: 12 weeks
measure: Lymphedema symptom changes
timeFrame: 12 weeks
measure: Number of lymphedema and venous related healthcare visits
timeFrame: 52 weeks
Secondary outcomes:
measure: Limb circumference changes after 12 weeks and 52 weeks of treatment
timeFrame: 12 weeks and 52 weeks
measure: Fibrosis grading changes after 12 weeks and 52 weeks of treatment
timeFrame: 12 weeks and 52 weeks
measure: Assessment of skin changes after 12 weeks and 52 weeks of treatment
timeFrame: 12 weeks and 52 weeks
measure: Lymphedema staging changes after 12 weeks and 52 weeks of treatment
timeFrame: 12 weeks and 52 weeks
measure: Quality of life changes: Questionnaires
timeFrame: 24 weeks and 52 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Healthcare System
state: Maryland
city: East Orange
country: United States
facility: VA New Jersey Health Care System (VANJHCS)
state: New Jersey
city: Brooklyn
country: United States
facility: VA NY Harbor Healthcare System - Brooklyn
state: New York
city: Buffalo
country: United States
facility: VA Western New York Healthcare System
state: New York
city: Jamaica
country: United States
facility: VA NY Harbor Healthcare System - St. Albans
state: New York
city: New York
country: United States
facility: VA NY Harbor Healthcare System - Manhattan
state: New York
Study officials:
affiliation: NYU
name: Thomas Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
References: