Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling)

Tactile Medical

Status

Completed

Conditions

Lipedema

Lipolymphedema

Treatments

Other: Conservative Care

Device: Flexitouch Plus and Conservative Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT04213989

1000

Details and patient eligibility

About

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).

Enrollment

36 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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