LymphedemaNCT04116099
CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema
An observational study of Lymphedema, run by Tactile Medical at 3 sites in United States.
Trial summary
Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- Conservative care and Flexitouch Plus
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Oct 2019to 24 Nov 2021
- How long will I take part?
- 12 Months
- 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: The study population will be drawn from vascular patients with lower extremity lymphedema that is unilateral or bilateral.
Who may be able to join
- Male or female 18 years of age or older.
- Diagnosis of lower extremity lymphedema (including primary, secondary, chronic venous insufficiency (CVI)-related, unilateral, or bilateral).
- Clinical Etiology Anatomy Pathophysiology (CEAP) Classification of C3 or higher.
- Willing to comply with prescribed care, protocol requirements, and study-related visits.
- Willing and able to provide consent to participate.
Who cannot join
- BMI > 50.
- Significant venous reflux disease, as determined by the investigator (e.g., indicated for venous intervention, post intervention with inadequate venous function, or ultrasound evidence of deep venous obstruction).
- Unresolved healing at the surgical site following a venous intervention (e.g., ablation, stenting, or venoplasty).
- Heart failure (acute pulmonary edema, decompensated acute heart failure).
- Acute venous disease (< 6 weeks) such as acute thrombophlebitis, acute deep venous thrombosis, or acute pulmonary embolism.
- Significant peripheral artery disease (ankle-brachial index (ABI) < 0.6, critical limb ischemia including ischemic rest pain, arterial wounds or gangrene).
Show all 12Show fewer
- Active skin or limb infection/ inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease).
- Active cancer (cancer that is currently under treatment, but not yet in remission).
- Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome.
- Any circumstance where increased lymphatic or venous return is undesirable.
- Currently pregnant or trying to become pregnant (for Flexitouch Plus and conservative care group).
- Current participation in any drug or other device clinical studies.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center for Vein Restoration - Glen Burnie
Glen Burnie, Maryland, 21061
Center for Vein Restoration - Greenbelt
Greenbelt, Maryland, 20770
Center for Vein Restoration - Silver Spring
Silver Spring, Maryland, 20903
About this study
Official title: An Observational Registry Evaluating the Flexitouch® Plus in Vascular Clinic Patients With Lower Extremity Lymphedema
Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.
Read the detailed description
Conservative care treatment for lymphedema may include use of compression, manual lymphatic drainage (MLD, performed either by a therapist or self-MLD), exercises and skin care. Subjects presenting to a vein clinic (Center for Vein Restoration or CVR) with lymphedema of the lower extremity/ies may receive a standard-of-care prescription for conservative care or for the Flexitouch Plus pneumatic compression device along with conservative care. Subjects will be followed (by phone and in clinic) for 12 months after initiating treatment for venous- and lymphedema-related complications, unscheduled visits, changes in quality of life measures and edema measures, skin changes, and changes to wounds (if present).
- Conditions
- Lymphedema
- Being tested
- Conservative care, Flexitouch Plus
- Keywords
- Lymphedema of Leg, Chronic Venous Insufficiency, 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.
Conservative careOther
May include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.
Flexitouch PlusDevice
Flexitouch Plus treatment.
| Study group | Role | What they receive |
|---|---|---|
| Conservative care alone | Conservative care alone which may include graduated compression, manual lymphatic drainage (MLD) performed by a licensed therapist, self-MLD, and instruction on exercise and skin care. Receives: Other: Conservative care | |
| Flexitouch Plus and conservative care | Flexitouch Plus and conservative care which includes Flexitouch Plus treatment as well as conservative care measures which may include graduated compression, manual lymphatic drainage (MLD) performed by a licensed therapist, self-MLD, and instruction on exercise and skin care. Receives: Other: Conservative care; Device: Flexitouch Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
To evaluate the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 12 months of treatment based upon the number of lymphedema and venous-related complications.
Measured: 12 months
Number of unscheduled visits
To evaluate the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 12 months of treatment based upon the number of lymphedema and venous-related unscheduled follow-up visits (non-routine clinic, hospital, urgent care, and emergency room visits).
Measured: 12 months
Secondary outcomes (8)
Quality of life changes: Short-Form 12 (SF-12)
To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in the SF-12. This survey includes 12 questions to measure physical and mental health from the patient's point of view. The questionnaire includes eight health domains: physical functioning, physical health problems, bodily pain, general health, vitality, social functioning, emotional health problems, and mental health. The scoring mechanism uses T scores for all surveys using means and standard deviations from the 1998 US general population. A higher score represents better function.
Measured: 6 months
Quality of life changes: Quality of Life with Venous Insufficiency (CIVIQ-20)
To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in the CIVIQ-20, which is a survey specific to assess patient-perceived quality of life with chronic venous disorders. The instrument reviews four dimensions - psychological (range 9-45), pain (range 4-20), physical (range 4-20), and social (range 3-15). A global index score can be obtained by adding up the scores of all 20 items (range 20-100). A low score corresponds to greater patient comfort.
Measured: 6 months
Quality of life changes: Lymphedema Quality of Life Tool (LYMQOL)
To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in the LYMQOL, used to assess lymphedema symptom changes. 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: 6 months
Quality of life changes: Clinical Global Impression of Change - Global Improvement (CGI-I)
To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon a clinician's response to one question at the 6 month follow-up visit pertaining to overall clinical improvement (range 1-7). A lower score signifies greater improvement.
Measured: 6 months
Quality of life changes: Patient Global Impression of Change (PGIC)
To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon the patient's response to one question at the 6 month follow-up visit pertaining to overall status change (range 1-7). A lower score signifies greater improvement.
Measured: 6 months
Edema measures
To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon changes in edema measures on affected/ most affected leg.
Measured: 6 months
Presence and severity of skin changes
To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon skin changes on affected/ most affected leg.
Measured: 6 months
Wound area
To evaluate the effectiveness of the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 6 months of treatment based upon percent wound area reduction in subjects presenting with wounds.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start10 Oct 2019
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Why it stopped: Covid impact - slow enrollment
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
- 63 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Pappas, Principal investigator, Center for Vein Restoration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116099
- Sponsor's protocol ID
- 5020
- Status last verified
- Mar 2022
- First submitted
- 11 Sep 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Registry Evaluating the Flexitouch® Plus in Vascular Clinic Patients With Lower Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT04116099
- Acronym / sponsor ID
- 5020
- Conditions
- Lymphedema
- Keywords
- Lymphedema of Leg, Chronic Venous Insufficiency, Primary Lymphedema, Secondary Lymphedema
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid impact - slow enrollment
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 4 Oct 2019 (actual)
- 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.
Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.
Detailed description
Conservative care treatment for lymphedema may include use of compression, manual lymphatic drainage (MLD, performed either by a therapist or self-MLD), exercises and skin care. Subjects presenting to a vein clinic (Center for Vein Restoration or CVR) with lymphedema of the lower extremity/ies may receive a standard-of-care prescription for conservative care or for the Flexitouch Plus pneumatic compression device along with conservative care. Subjects will be followed (by phone and in clinic) for 12 months after initiating treatment for venous- and lymphedema-related complications, unscheduled visits, changes in quality of life measures and edema measures, skin changes, and changes to wounds (if present).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative care alone | – | Other: Conservative careConservative care alone which may include graduated compression, manual lymphatic drainage (MLD) performed by a licensed therapist, self-MLD, and instruction on exercise and skin care. |
| Flexitouch Plus and conservative care | – | Other: Conservative care, Device: Flexitouch PlusFlexitouch Plus and conservative care which includes Flexitouch Plus treatment as well as conservative care measures which may include graduated compression, manual lymphatic drainage (MLD) performed by a licensed therapist, self-MLD, and instruction on exercise and skin care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be drawn from vascular patients with lower extremity lymphedema that is unilateral or bilateral.
Key inclusion criteria (5 listed)
- Male or female 18 years of age or older.
- Diagnosis of lower extremity lymphedema (including primary, secondary, chronic venous insufficiency (CVI)-related, unilateral, or bilateral).
- Clinical Etiology Anatomy Pathophysiology (CEAP) Classification of C3 or higher.
- Willing to comply with prescribed care, protocol requirements, and study-related visits.
- Willing and able to provide consent to participate.
Key exclusion criteria (12 listed)
- BMI > 50.
- Significant venous reflux disease, as determined by the investigator (e.g., indicated for venous intervention, post intervention with inadequate venous function, or ultrasound evidence of deep venous obstruction).
- Unresolved healing at the surgical site following a venous intervention (e.g., ablation, stenting, or venoplasty).
- Heart failure (acute pulmonary edema, decompensated acute heart failure).
- Acute venous disease (< 6 weeks) such as acute thrombophlebitis, acute deep venous thrombosis, or acute pulmonary embolism.
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 |
|---|---|---|
| Conservative careMay include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin care. | Other | Conservative care alone, Flexitouch Plus and conservative care |
| Flexitouch PlusFlexitouch Plus treatment. | Device | Flexitouch Plus and conservative care |
Primary outcome
Complications
Time frame: 12 months
To evaluate the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 12 months of treatment based upon the number of lymphedema and venous-related complications.
Number of unscheduled visits
Time frame: 12 months
To evaluate the Flexitouch Plus and conservative care, compared to conservative care alone, in vascular patients with lower extremity lymphedema after 12 months of treatment based upon the number of lymphedema and venous-related unscheduled follow-up visits (non-routine clinic, hospital, urgent care, and emergency room visits).
8 secondary outcomes
Quality of life changes: Short-Form 12 (SF-12)
Time frame: 6 months
Quality of life changes: Quality of Life with Venous Insufficiency (CIVIQ-20)
Time frame: 6 months
Quality of life changes: Lymphedema Quality of Life Tool (LYMQOL)
Time frame: 6 months
Quality of life changes: Clinical Global Impression of Change - Global Improvement (CGI-I)
Time frame: 6 months
Quality of life changes: Patient Global Impression of Change (PGIC)
Time frame: 6 months
Edema measures
Time frame: 6 months
Presence and severity of skin changes
Time frame: 6 months
Wound area
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Covid impact - slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
Peter Pappas principal investigator
Center for Vein Restoration
3 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 3 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 12 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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: Covid impact - slow enrollment). 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?
Complications (time frame: 12 months). The study lists 2 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 31 Mar 2022.