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

NCT ID: NCT04213989

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2021-11-24

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).

Conditions

Lipedema; Lipolymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Conservative Care

Conservative care (may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT)

Group Type: ACTIVE_COMPARATOR

Conservative Care

Intervention Type: OTHER

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

Flexitouch Plus and Conservative Care

Flexitouch Plus with conservative care

Group Type: EXPERIMENTAL

Flexitouch Plus and Conservative Care

Intervention Type: 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.

Interventions

Flexitouch Plus and Conservative Care

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: DEVICE

Conservative Care

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

Intervention Type: OTHER

Other Intervention Names

Flexitouch system

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tactile Medical

INDUSTRY

Sponsor Role: collaborator

Thomas Wright, MD

INDUSTRY

Sponsor Role: lead

Responsible Party

Thomas Wright, MD

MD, FACPh, FACP, RVT

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Lakeview Medical Group, Inc

Locations

Laser Lipo and Vein Center

O'Fallon, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1000

Identifier Type: -

Identifier Source: org_study_id