Clinical trial NCT04213989: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lipedema
Lipolymphedema
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
Collaborators: name: Tactile Medical
First posted: 2019-12-30
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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).


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

Primary outcomes:
measure: Change in Circumferential Measurements Over Time
timeFrame: Changes between Screening and 3-4 weeks will be assessed
measure: Patient-Reported Quality of Life
timeFrame: Changes between Screening and 3-4 weeks will be assessed
measure: Patient-Reported Pain Interference
timeFrame: Changes between Screening and 3-4 weeks will be assessed
measure: Patient-Reported Pain
timeFrame: Changes between Screening and 3-4 weeks will be assessed
measure: Patient-Reported Symptoms of Lipo-Lymphedema
timeFrame: Changes between Screening and 3-4 weeks will be assessed
Secondary outcomes:
measure: Patient-Reported Mobility
timeFrame: Changes between Screening and 3-4 weeks will be assessed
measure: Change in Bioimpedance Measurements Over Time
timeFrame: Changes between Screening and 3-4 weeks will be assessed
Other outcomes:
Locations:
city: O'Fallon
country: United States
facility: Laser Lipo and Vein Center
state: Missouri
Study officials:
affiliation: Lakeview Medical Group, Inc
name: Thomas Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: