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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2023-02-01

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.

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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.

Conditions

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Lymphedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Advanced Pneumatic Compression Group

All study participants will receive treatment using an advanced pneumatic compression device.

Advanced Pneumatic Compression Device

Intervention Type DEVICE

Advanced Pneumatic Compression Device

Interventions

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Advanced Pneumatic Compression Device

Intervention Type DEVICE

Other Intervention Names

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Flexitouch system Flexitouch Plus

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No