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

T

Tactile Medical

Status

Terminated

Conditions

Lymphedema

Treatments

Device: Advanced Pneumatic Compression Device

Study type

Observational

Funder types

Industry

Identifiers

NCT02661646
5010

Details and patient eligibility

About

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.

Full 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.

Enrollment

249 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

249 participants in 1 patient group

Advanced Pneumatic Compression Group
Description:
All study participants will receive treatment using an advanced pneumatic compression device.
Treatment:
Device: Advanced Pneumatic Compression Device

Trial documents
2

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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