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NCT Number: NCT04213989

Intermittent Pneumatic Compression 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.

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).

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Key information

Conditions

Lipedema Connective Tissue Diseases Lipolymphedema Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laser Lipo and Vein Center

O'Fallon, Missouri, 63368, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flexitouch Plus and Conservative Care

Device

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.

Other names: Flexitouch system

Conservative Care

Other

May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.

Primary outcomes

  1. Change in Circumferential Measurements Over Time

    Time frame: Changes between Screening and 3-4 weeks will be assessed

    Tape measurements along both legs

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Patient-Reported Mobility

    Time frame: 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.

  2. Change in Bioimpedance Measurements Over Time

    Time frame: Changes between Screening and 3-4 weeks will be assessed

    InBody 770 whole body and segmental extracorporeal body weight / total body weight ratios

Sponsors and collaborators

Lead sponsor

Thomas Wright, MD

Industry

Collaborators

  • Tactile Medical

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2019
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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