Lipedema, Lipolymphedema
Conditions
Brief 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). 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).
Interventions
DEVICEFlexitouch Plus and Conservative Care
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.
OTHERConservative Care
May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Sponsors
Tactile Medical
Thomas Wright, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Quality of Life | 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 | 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 | 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. |
| Change in Circumferential Measurements Over Time | Changes between Screening and 3-4 weeks will be assessed | Tape measurements along both legs |
| Patient-Reported Pain Interference | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bioimpedance Measurements Over Time | Changes between Screening and 3-4 weeks will be assessed | InBody 770 whole body and segmental extracorporeal body weight / total body weight ratios |
| Patient-Reported Mobility | Changes between Screening and 3-4 weeks will be assessed | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conservative Care Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Conservative Care: May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT. | 14 |
| Flexitouch Plus and Conservative Care Flexitouch Plus with conservative care
Flexitouch Plus and Conservative Care: 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. | 12 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Conservative Care | Flexitouch Plus and Conservative Care | Total |
|---|---|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 9.6 | 44.6 years STANDARD_DEVIATION 9.5 | 43.3 years STANDARD_DEVIATION 9.4 |
| BMI | 37.0 kg/m^2 STANDARD_DEVIATION 7.5 | 35.9 kg/m^2 STANDARD_DEVIATION 5.2 | 36.5 kg/m^2 STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 12 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 12 Participants | 24 Participants |
| Region of Enrollment United States | 14 participants | 12 participants | 26 participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 14 | 0 / 12 |
Outcome results
Primary
Change in Circumferential Measurements Over Time
Tape measurements along both legs
Time frame: Changes between Screening and 3-4 weeks will be assessed
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Conservative Care | Change in Circumferential Measurements Over Time | Ankle | -0.5 cm |
| Conservative Care | Change in Circumferential Measurements Over Time | Calf | -1.3 cm |
| Conservative Care | Change in Circumferential Measurements Over Time | Knee | -2.4 cm |
| Conservative Care | Change in Circumferential Measurements Over Time | Thigh | -1.7 cm |
| Conservative Care | Change in Circumferential Measurements Over Time | Hip | -0.4 cm |
| Conservative Care | Change in Circumferential Measurements Over Time | Waist | -2.4 cm |
| Flexitouch Plus and Conservative Care | Change in Circumferential Measurements Over Time | Hip | 3.2 cm |
| Flexitouch Plus and Conservative Care | Change in Circumferential Measurements Over Time | Ankle | -1.0 cm |
| Flexitouch Plus and Conservative Care | Change in Circumferential Measurements Over Time | Thigh | -3.0 cm |
| Flexitouch Plus and Conservative Care | Change in Circumferential Measurements Over Time | Calf | -2.0 cm |
| Flexitouch Plus and Conservative Care | Change in Circumferential Measurements Over Time | Waist | -2.3 cm |
| Flexitouch Plus and Conservative Care | Change in Circumferential Measurements Over Time | Knee | -4.7 cm |
Primary
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.
Time frame: Changes between Screening and 3-4 weeks will be assessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Conservative Care | Patient-Reported Pain | -0.8 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Pain | -0.8 score on a scale |
Primary
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.
Time frame: Changes between Screening and 3-4 weeks will be assessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Conservative Care | Patient-Reported Pain Interference | -1.4 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Pain Interference | -3.0 score on a scale |
Primary
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.
Time frame: Changes between Screening and 3-4 weeks will be assessed
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Conservative Care | Patient-Reported Quality of Life | General health | -2.7 score on a scale |
| Conservative Care | Patient-Reported Quality of Life | Physical functioning | 2.6 score on a scale |
| Conservative Care | Patient-Reported Quality of Life | Role limitations due to physical functioning | -1.2 score on a scale |
| Conservative Care | Patient-Reported Quality of Life | Emotional wellbeing | 2.8 score on a scale |
| Conservative Care | Patient-Reported Quality of Life | Role limitations due to emotional problems | -10.9 score on a scale |
| Conservative Care | Patient-Reported Quality of Life | Energy/fatigue | 4.8 score on a scale |
| Conservative Care | Patient-Reported Quality of Life | Social functioning | 9.9 score on a scale |
| Conservative Care | Patient-Reported Quality of Life | Pain | 4.5 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Quality of Life | Pain | 10.2 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Quality of Life | General health | 1.3 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Quality of Life | Role limitations due to emotional problems | -2.2 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Quality of Life | Physical functioning | 5.3 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Quality of Life | Social functioning | -2.2 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Quality of Life | Role limitations due to physical functioning | 1.4 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Quality of Life | Energy/fatigue | 0.7 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Quality of Life | Emotional wellbeing | -1.0 score on a scale |
Primary
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.
Time frame: Changes between Screening and 3-4 weeks will be assessed
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Fatigue-Left Leg | -1.4 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Tenderness-Left Leg | -0.6 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Pain-Left Leg | -0.3 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Tightness-Right Leg | -0.9 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Tightness-Left Leg | -1.2 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Swelling-Left Leg | -0.5 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Heaviness-Left Leg | -0.9 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Swelling-Right Leg | -0.7 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Pain-Right Leg | -0.1 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Heaviness-Right Leg | -0.8 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Fatigue-Right Leg | -1.8 score on a scale |
| Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Tenderness-Right Leg | -0.1 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Heaviness-Right Leg | -0.5 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Heaviness-Left Leg | -1.0 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Pain-Left Leg | -1.4 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Tenderness-Left Leg | -0.2 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Tightness-Left Leg | -1.8 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Swelling-Left Leg | -0.2 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Fatigue-Right Leg | -0.3 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Tenderness-Right Leg | 0.1 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Tightness-Right Leg | -1.6 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Fatigue-Left Leg | -0.6 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Swelling-Right Leg | 0.1 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Symptoms of Lipo-Lymphedema | Pain-Right Leg | -0.5 score on a scale |
Secondary
Change in Bioimpedance Measurements Over Time
InBody 770 whole body and segmental extracorporeal body weight / total body weight ratios
Time frame: Changes between Screening and 3-4 weeks will be assessed
Population: Each participant underwent circumferential measurement at baseline and at follow-up. Patients were measured at 4 sites on each leg (narrowest part of the ankle, largest part of the calf, top of knee cap, and thickest part of the upper thigh), the widest part of the hips and the widest part of the waist.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Conservative Care | Change in Bioimpedance Measurements Over Time | Whole body | -0.001 ohms |
| Conservative Care | Change in Bioimpedance Measurements Over Time | Trunk | -0.001 ohms |
| Conservative Care | Change in Bioimpedance Measurements Over Time | Arms | 0.000 ohms |
| Conservative Care | Change in Bioimpedance Measurements Over Time | Legs | -0.003 ohms |
| Flexitouch Plus and Conservative Care | Change in Bioimpedance Measurements Over Time | Legs | -0.004 ohms |
| Flexitouch Plus and Conservative Care | Change in Bioimpedance Measurements Over Time | Whole body | -0.002 ohms |
| Flexitouch Plus and Conservative Care | Change in Bioimpedance Measurements Over Time | Arms | 0.000 ohms |
| Flexitouch Plus and Conservative Care | Change in Bioimpedance Measurements Over Time | Trunk | -0.002 ohms |
Secondary
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.
Time frame: Changes between Screening and 3-4 weeks will be assessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Conservative Care | Patient-Reported Mobility | 2.9 score on a scale |
| Flexitouch Plus and Conservative Care | Patient-Reported Mobility | -0.6 score on a scale |