LymphedemaNCT02661646
Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD)
An observational study of Lymphedema, run by Tactile Medical at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- Advanced Pneumatic Compression Device
- Type of treatment
- Medical device
- How many people
- 249 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2015to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
VA Maryland Healthcare System
Baltimore, Maryland, 21201
VA NY Harbor Healthcare System - Brooklyn
Brooklyn, New York, 11209
VA Western New York Healthcare System
Buffalo, New York, 14215
VA New Jersey Health Care System (VANJHCS)
East Orange, New Jersey, 07018
VA NY Harbor Healthcare System - St. Albans
Jamaica, New York, 11425
VA NY Harbor Healthcare System - Manhattan
New York, New York, 10010
About this study
Official title: Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home
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.
Read the 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.
- Conditions
- Lymphedema
- Being tested
- Advanced Pneumatic Compression Device
- Keywords
- Chronic Swelling, Leg Lymphedema, Primary Lymphedema, Secondary Lymphedema
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Pneumatic Compression DeviceDevice
Also called Flexitouch system, Flexitouch Plus
Advanced Pneumatic Compression Device
| Study group | Role | What they receive |
|---|---|---|
| Advanced Pneumatic Compression Group | All study participants will receive treatment using an advanced pneumatic compression device. Receives: Device: Advanced Pneumatic Compression Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life changes: Questionnaires
Questionnaires to assess quality of life changes after 12 weeks of treatment
Measured: 12 weeks
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.
Measured: 12 weeks
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)
Measured: 52 weeks
Secondary outcomes (5)
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
Measured: 12 weeks and 52 weeks
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
Measured: 12 weeks and 52 weeks
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
Measured: 12 weeks and 52 weeks
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
Measured: 12 weeks and 52 weeks
Quality of life changes: Questionnaires
Questionnaires to assess quality of life changes after 24 weeks of treatment
Measured: 24 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startDec 2015
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: Due to slow enrollment during COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Maldonado, MD, Principal investigator, NYU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661646
- Sponsor's protocol ID
- 5010
- Status last verified
- Mar 2023
- First submitted
- 18 Jan 2016
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home
- ClinicalTrials.gov ID
- NCT02661646
- Acronym / sponsor ID
- 5010
- Conditions
- Lymphedema
- Keywords
- Chronic Swelling, Leg Lymphedema, Primary Lymphedema, Secondary Lymphedema
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to slow enrollment during COVID
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Pneumatic Compression Group | – | Device: Advanced Pneumatic Compression DeviceAll study participants will receive treatment using an advanced pneumatic compression device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Pneumatic Compression DeviceAlso: Flexitouch system, Flexitouch PlusAdvanced Pneumatic Compression Device | Device | Advanced Pneumatic Compression Group |
Primary outcome
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.
Number of lymphedema and venous related healthcare visits
Time frame: 52 weeks
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)
5 secondary outcomes
Limb circumference changes after 12 weeks and 52 weeks of treatment
Time frame: 12 weeks and 52 weeks
Fibrosis grading changes after 12 weeks and 52 weeks of treatment
Time frame: 12 weeks and 52 weeks
Assessment of skin changes after 12 weeks and 52 weeks of treatment
Time frame: 12 weeks and 52 weeks
Lymphedema staging changes after 12 weeks and 52 weeks of treatment
Time frame: 12 weeks and 52 weeks
Quality of life changes: Questionnaires
Time frame: 24 weeks and 52 weeks
Results and safety
The study was stopped early (reason given: Due to slow enrollment during COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Maldonado, MD principal investigator
NYU
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by Tactile Medical at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to slow enrollment during COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life changes: Questionnaires (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.