Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)
Primary Purpose
Lipedema, Lipolymphedema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flexitouch Plus and Conservative Care
Conservative Care
Sponsored by
About this trial
This is an interventional supportive care trial for Lipedema
Eligibility Criteria
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
Sites / Locations
- Laser Lipo and Vein Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conservative Care
Flexitouch Plus and Conservative Care
Arm Description
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Flexitouch Plus with conservative care
Outcomes
Primary Outcome Measures
Change in Circumferential Measurements Over Time
Tape measurements along both legs
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.
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.
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.
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.
Secondary Outcome Measures
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.
Change in Bioimpedance Measurements Over Time
InBody 770 whole body and segmental extracorporeal body weight / total body weight ratios
Full Information
NCT ID
NCT04213989
First Posted
December 21, 2019
Last Updated
July 29, 2022
Sponsor
Thomas Wright, MD
Collaborators
Tactile Medical
1. Study Identification
Unique Protocol Identification Number
NCT04213989
Brief Title
Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Wright, MD
Collaborators
Tactile Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipedema, Lipolymphedema
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conservative Care
Arm Type
Active Comparator
Arm Description
Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)
Arm Title
Flexitouch Plus and Conservative Care
Arm Type
Experimental
Arm Description
Flexitouch Plus with conservative care
Intervention Type
Device
Intervention Name(s)
Flexitouch Plus and Conservative Care
Other Intervention Name(s)
Flexitouch system
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conservative Care
Intervention Description
May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Primary Outcome Measure Information:
Title
Change in Circumferential Measurements Over Time
Description
Tape measurements along both legs
Time Frame
Changes between Screening and 3-4 weeks will be assessed
Title
Patient-Reported Quality of Life
Description
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
Title
Patient-Reported Pain Interference
Description
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
Title
Patient-Reported Pain
Description
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
Title
Patient-Reported Symptoms of Lipo-Lymphedema
Description
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
Secondary Outcome Measure Information:
Title
Patient-Reported Mobility
Description
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
Title
Change in Bioimpedance Measurements Over Time
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Wright, MD
Organizational Affiliation
Lakeview Medical Group, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser Lipo and Vein Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)
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