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

Lymphedema Clinical Trial

Official title:

Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02661646
• Other study ID #: 5010
• Status: Terminated
• Start date: December 2015
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2023
• Source: Tactile Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 249
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• Advanced Pneumatic Compression Device
Advanced Pneumatic Compression Device

Locations

Country	Name	City	State
United States	VA Maryland Healthcare System	Baltimore	Maryland
United States	VA NY Harbor Healthcare System - Brooklyn	Brooklyn	New York
United States	VA Western New York Healthcare System	Buffalo	New York
United States	VA New Jersey Health Care System (VANJHCS)	East Orange	New Jersey
United States	VA NY Harbor Healthcare System - St. Albans	Jamaica	New York
United States	VA NY Harbor Healthcare System - Manhattan	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tactile Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life changes: Questionnaires	Questionnaires to assess quality of life changes after 12 weeks of treatment	12 weeks
Primary	Lymphedema symptom changes	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.	12 weeks
Primary	Number of lymphedema and venous related healthcare visits	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)	52 weeks
Secondary	Limb circumference changes after 12 weeks and 52 weeks of treatment	Comparison of changes in limb circumference after 12 weeks and 52 weeks of treatment	12 weeks and 52 weeks
Secondary	Fibrosis grading changes after 12 weeks and 52 weeks of treatment	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	12 weeks and 52 weeks
Secondary	Assessment of skin changes after 12 weeks and 52 weeks of treatment	Comparison of changes in the presence of skin conditions based on clinician observation after 12 weeks and 52 weeks of treatment	12 weeks and 52 weeks
Secondary	Lymphedema staging changes after 12 weeks and 52 weeks of treatment	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	12 weeks and 52 weeks
Secondary	Quality of life changes: Questionnaires	Questionnaires to assess quality of life changes after 24 weeks of treatment	24 weeks and 52 weeks