Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)
Condition: Lipedema; Lipolymphedema
MeSH terms: Lymphedema; Lipedema
Study type: Interventional

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).
    


Intervention name(s): Flexitouch Plus and Conservative Care; Conservative Care
Intervention type(s): Device; Other
Intervention description(s): 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.; May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
Other intervention name(s): Flexitouch system
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Supportive Care