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

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ClinicalTrials.gov Identifier: NCT02661646
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tactile Medical

Tracking Information
First Submitted Date January 18, 2016
First Posted Date January 22, 2016
Last Update Posted Date March 18, 2019
Actual Study Start Date December 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2019)
  • Quality of life changes: Questionnaires [ Time Frame: 12 weeks ]
    Questionnaires to assess quality of life changes after 12 weeks of treatment
  • Lymphedema symptom changes [ Time Frame: 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.
  • Lymphedema and venous related complication rate changes [ Time Frame: 52 weeks ]
    Comparison of the lymphedema and venous related complication rates in the year preceding treatment and the during the 52 weeks while receiving treatment
  • Lymphedema and venous related unscheduled visit rate changes [ Time Frame: 52 weeks ]
    Comparison of the lymphedema and venous related unscheduled visit rates in the year preceding treatment and the during the 52 weeks while receiving treatment
Original Primary Outcome Measures
 (submitted: January 20, 2016)
Quality of life [ Time Frame: 12 weeks ]
Questionnaires to assess quality of life changes after 12 weeks of treatment
Change History Complete list of historical versions of study NCT02661646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 14, 2019)
  • Limb circumference changes after 12 weeks and 52 weeks of treatment [ Time Frame: 12 weeks and 52 weeks ]
    Comparison of changes in limb circumference after 12 weeks and 52 weeks of treatment
  • Fibrosis grading changes after 12 weeks and 52 weeks of treatment [ Time Frame: 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 [ Time Frame: 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
  • Lymphedema staging changes after 12 weeks and 52 weeks of treatment [ Time Frame: 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
  • Quality of life changes: Questionnaires [ Time Frame: 24 weeks ]
    Questionnaires to assess quality of life changes after 24 weeks of treatment
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Lymphedema
Intervention Device: Advanced Pneumatic Compression Device
Advanced Pneumatic Compression Device
Other Names:
  • Flexitouch system
  • Flexitouch Plus
Study Groups/Cohorts Advanced Pneumatic Compression Group
All study participants will receive treatment using an advanced pneumatic compression device.
Intervention: Device: Advanced Pneumatic Compression Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 20, 2016)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jill Christensen jchristensen@tactilemedical.com
Contact: Suzanne Hansel shansel@tactilemedical.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02661646
Other Study ID Numbers 5010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Tactile Medical
Study Sponsor Tactile Medical
Collaborators Not Provided
Investigators
Principal Investigator: Thomas Maldonado, MD NYU
PRS Account Tactile Medical
Verification Date March 2019