LipedemaNCT04213989
Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)
A study testing Flexitouch Plus and Conservative Care and Conservative Care in people with Lipedema and Lipolymphedema, run by Thomas Wright, MD at 1 site in United States.
Trial summary
Lipedema is a connective tissue disorder that affects up to 10% of women. It is characterized by painful, swollen subcutaneous tissue and disproportionate fat accumulation (primarily in the lower limbs, however it can spread to the abdomen and arms). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Lipedema, Lipolymphedema
- What is being tested?
- Flexitouch Plus and Conservative Care and Conservative Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 24 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female age 18-70 years
- Stage 2-3 (Schmeller Type 2-3) lipedema with secondary lymphedema
- Willing and able to follow prescribed care for study period
- Able to access (via self-pay, patient assistance, or insurance programs) prescribed care within 60 days of Screening visit
Who cannot join
- BMI > 50
- Heart failure (acute pulmonary edema, decompensated acute heart failure)
- Pacemaker or implantable cardioverter defibrillator (ICD)
- Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)
- Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Laser Lipo and Vein Center
O'Fallon, Missouri, 63368
About this study
Official title: An Investigator-initiated Study Assessing the Effect of Intermittent Pneumatic Compression (IPC) on Symptoms and Quality of Life in Women With Lipo-lymphedema (Lipedema With Swelling)
Lipedema is a connective tissue disorder that affects up to 10% of women. It is characterized by painful, swollen subcutaneous tissue and disproportionate fat accumulation (primarily in the lower limbs, however it can spread to the abdomen and arms). Patients are often not aware they are affected by this disease; rather, they think they are just overweight or obese.
Patients with lipedema often feel frustrated and uncomfortable as symptoms such as heaviness, pain, and easy bruising impact quality of life. Affected limbs can become so large and heavy that daily tasks such as walking, cleaning, or shopping become impossible.
Read more
There is currently no cure for lipedema, thus treatment focuses on symptom management and improved patient-reported outcomes. At present, the two main courses of treatment include non-surgical conservative treatment (e.g., Comprehensive Decongestive Therapy (CDT), diet, exercise, emotional/psychological/social support) and lymph-sparing liposuction performed by a surgeon trained in lipedema treatment. The primary goals for treatment include: reduction/elimination of inflammation, swelling, and pain; increase in lymphatic flow, which reduces/eliminates excessive fluid and swelling; overall management of the physical impact of lipedema; and quality of life improvements which can include emotional, psychological/mental, spiritual, and social enhancement in addition to physical management.
Intermittent Pneumatic Compression (IPC) devices are often used as home-therapy to treat secondary lymphedema or lipo-lymphedema (lipedema with swelling) and may be helpful in preventing the progression of lipedema. IPC use moves lymphatic fluid and supports the elimination of proteinaceous fluids, thus leading to improved patient-reported symptoms, decreased limb girth and volume, increased elasticity of tissues, and fewer episodes of infection.
The purpose of this study is to assess whether 3-4 weeks of IPC usage is associated with alleviation of symptoms and improvement in quality of life in women with lipo-lymphedema (lipedema with swelling).
- Conditions
- Lipedema, Lipolymphedema
- Being tested
- Flexitouch Plus and Conservative Care, Conservative Care
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexitouch Plus and Conservative CareDevice
Also called Flexitouch system
A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Conservative CareOther
May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Care | Active comparator | Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) Receives: Other: Conservative Care |
| Flexitouch Plus and Conservative Care | Experimental | Flexitouch Plus with conservative care Receives: Device: Flexitouch Plus and Conservative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Circumferential Measurements Over Time
Tape measurements along both legs
Measured: Changes between Screening and 3-4 weeks will be assessed
Patient-Reported Quality of Life
RAND 36-Item Short Form Survey Instrument (SF-36) 1.0 is a global assessment of health impacts on quality of life that taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Measured: Changes between Screening and 3-4 weeks will be assessed
Patient-Reported Pain Interference
PROMIS Item Bank v1.0 - Pain Interference - Short Form 6b is a 6 item survey that measures self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. All items are scored so that a low score is associated with less pain interference (a more favorable health state). In addition, each item is scored on a 1 to 5 range so that the lowest and highest possible scores are 6 and 30, respectively.
Measured: Changes between Screening and 3-4 weeks will be assessed
Patient-Reported Pain
Wong Baker Faces Scale is a self-assessment tool that is easily understood by patients, so they are able to choose the face that best illustrates the physical pain they are experiencing associated with their lipo-lymphedema. Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain.
Measured: Changes between Screening and 3-4 weeks will be assessed
Patient-Reported Symptoms of Lipo-Lymphedema
NRS Symptom Survey is a 6-item survey that asks patients to rate their perceptions of swelling, heaviness, pain, fatigue, tenderness, and tightness independently for each leg using a 10-point numerical rating scale where 0 represents none/not present and 10 is worst imaginable. All items are scored so that a low score is associated with fewer symptoms (defines a more favorable health state). The lowest and highest possible scores per leg are 0 and 60, respectively, with a combined total score between 0 and 120.
Measured: Changes between Screening and 3-4 weeks will be assessed
Secondary outcomes (2)
Patient-Reported Mobility
PROMIS Item Bank v2.0 - Mobility is a 15-item survey that focuses on activities of physical mobility such as getting out of bed or a chair to activities such as running. All items are scored so that a high score is associated with more mobility (a more favorable health state). In addition, each item is scored on a 5 to 1 range so that the highest and lowest possible scores are 75 and 15, respectively.
Measured: Changes between Screening and 3-4 weeks will be assessed
Change in Bioimpedance Measurements Over Time
InBody 770 whole body and segmental extracorporeal body weight / total body weight ratios
Measured: Changes between Screening and 3-4 weeks will be assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start31 Jan 2020
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LipedemaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized to conservative care or Flexitouch Plus and conservative care at Screening. Subjects have up to 60 days to acquire treatment through commercial means and commence treatment. Follow-up will take place 3-4 weeks after treatment commences.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Wright, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tactile Medical
- Responsible party
- Sponsor-investigator, Thomas Wright, MD, Tactile Medical
- Investigators
- Thomas Wright, MD, Principal investigator, Lakeview Medical Group, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213989
- Sponsor's protocol ID
- 1000
- Status last verified
- Jul 2022
- First submitted
- 21 Dec 2019
- Last updated
- 23 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Study Assessing the Effect of Intermittent Pneumatic Compression (IPC) on Symptoms and Quality of Life in Women With Lipo-lymphedema (Lipedema With Swelling)
- ClinicalTrials.gov ID
- NCT04213989
- Acronym / sponsor ID
- 1000
- Conditions
- Lipedema, Lipolymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Thomas Wright, MDIndustry (pharma, biotech, devices)
- Collaborators
- Tactile Medical
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Posted 23 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lipedema is a connective tissue disorder that affects up to 10% of women. It is characterized by painful, swollen subcutaneous tissue and disproportionate fat accumulation (primarily in the lower limbs, however it can spread to the abdomen and arms). Patients are often not aware they are affected by this disease; rather, they think they are just overweight or obese.
Patients with lipedema often feel frustrated and uncomfortable as symptoms such as heaviness, pain, and easy bruising impact quality of life. Affected limbs can become so large and heavy that daily tasks such as walking, cleaning, or shopping become impossible.
There is currently no cure for lipedema, thus treatment focuses on symptom management and improved patient-reported outcomes. At present, the two main courses of treatment include non-surgical conservative treatment (e.g., Comprehensive Decongestive Therapy (CDT), diet, exercise, emotional/psychological/social support) and lymph-sparing liposuction performed by a surgeon trained in lipedema treatment. The primary goals for treatment include: reduction/elimination of inflammation, swelling, and pain; increase in lymphatic flow, which reduces/eliminates excessive fluid and swelling; overall management of the physical impact of lipedema; and quality of life improvements which can include emotional, psychological/mental, spiritual, and social enhancement in addition to physical management.
Intermittent Pneumatic Compression (IPC) devices are often used as home-therapy to treat secondary lymphedema or lipo-lymphedema (lipedema with swelling) and may be helpful in preventing the progression of lipedema. IPC use moves lymphatic fluid and supports the elimination of proteinaceous fluids, thus leading to improved patient-reported symptoms, decreased limb girth and volume, increased elasticity of tissues, and fewer episodes of infection.
The purpose of this study is to assess whether 3-4 weeks of IPC usage is associated with alleviation of symptoms and improvement in quality of life in women with lipo-lymphedema (lipedema with swelling).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized to conservative care or Flexitouch Plus and conservative care at Screening. Subjects have up to 60 days to acquire treatment through commercial means and commence treatment. Follow-up will take place 3-4 weeks after treatment commences.
| Arm | Type | Receives |
|---|---|---|
| Conservative Care | Active comparator | Other: Conservative CareConservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT) |
| Flexitouch Plus and Conservative Care | Experimental | Device: Flexitouch Plus and Conservative CareFlexitouch Plus with conservative care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female age 18-70 years
- Stage 2-3 (Schmeller Type 2-3) lipedema with secondary lymphedema
- Willing and able to follow prescribed care for study period
- Able to access (via self-pay, patient assistance, or insurance programs) prescribed care within 60 days of Screening visit
Key exclusion criteria (10 listed)
- BMI > 50
- Heart failure (acute pulmonary edema, decompensated acute heart failure)
- Pacemaker or implantable cardioverter defibrillator (ICD)
- Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)
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 |
|---|---|---|
| Flexitouch Plus and Conservative CareAlso: Flexitouch systemA segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT. | Device | Flexitouch Plus and Conservative Care |
| Conservative CareMay include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT. | Other | Conservative Care |
Primary outcome
Change in Circumferential Measurements Over Time
Time frame: Changes between Screening and 3-4 weeks will be assessed
Tape measurements along both legs
Patient-Reported Quality of Life
Time frame: Changes between Screening and 3-4 weeks will be assessed
RAND 36-Item Short Form Survey Instrument (SF-36) 1.0 is a global assessment of health impacts on quality of life that taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Patient-Reported Pain Interference
Time frame: Changes between Screening and 3-4 weeks will be assessed
PROMIS Item Bank v1.0 - Pain Interference - Short Form 6b is a 6 item survey that measures self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. All items are scored so that a low score is associated with less pain interference (a more favorable health state). In addition, each item is scored on a 1 to 5 range so that the lowest and highest possible scores are 6 and 30, respectively.
Patient-Reported Pain
Time frame: Changes between Screening and 3-4 weeks will be assessed
Wong Baker Faces Scale is a self-assessment tool that is easily understood by patients, so they are able to choose the face that best illustrates the physical pain they are experiencing associated with their lipo-lymphedema. Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain.
Patient-Reported Symptoms of Lipo-Lymphedema
Time frame: Changes between Screening and 3-4 weeks will be assessed
NRS Symptom Survey is a 6-item survey that asks patients to rate their perceptions of swelling, heaviness, pain, fatigue, tenderness, and tightness independently for each leg using a 10-point numerical rating scale where 0 represents none/not present and 10 is worst imaginable. All items are scored so that a low score is associated with fewer symptoms (defines a more favorable health state). The lowest and highest possible scores per leg are 0 and 60, respectively, with a combined total score between 0 and 120.
2 secondary outcomes
Patient-Reported Mobility
Time frame: Changes between Screening and 3-4 weeks will be assessed
Change in Bioimpedance Measurements Over Time
Time frame: Changes between Screening and 3-4 weeks will be assessed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Wright, MD principal investigator
Lakeview Medical Group, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexitouch Plus and Conservative Care and Conservative Care in people with Lipedema and Lipolymphedema, run by Thomas Wright, MD at 1 site 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 23 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Circumferential Measurements Over Time (time frame: Changes between Screening and 3-4 weeks will be assessed). The study lists 5 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 23 Aug 2022.