Effects of Intermittent Pneumatic Compression Therapy on Tissue Volume, Pain, and Quality of Life in Lipedema
NCT Number: NCT06549738
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lipedema
Interventions: DEVICE: Intermittent pneumatic compression therapy
Sponsor: Lympha Press
Collaborators: Carolina Vein Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-21
Completion Date: 2023-11-16
Locations: Carolina Vein Center, Durham, North Carolina, 27713, United States

Summary:
Lipedema is an inflammatory and painful disease of subcutaneous adipose tissue (SAT) in women that is associated with vein disease and lymphedema. There is controversy on whether there is edema in lipedema. This study seeks to determine: 1. Is there is edema in lipedema? 2. Can edema, lipedema subcutaneous adipose tissue (SAT), symptoms, and quality of life be improved by an advanced intermittent pneumatic compression device (IPCD)?

During the course of the study subjects will be seen three times in the clinic for assessment and measurements. All subjects will be provided a compression legging at the first clinic visit. Half of the subjects (the treatment group) will be provided and use an advanced intermittent pneumatic compression device with pants-type appliance that applies dynamic compression therapy to the abdomen, hips, buttocks, legs and feet, starting at the second visit, for 30 days at home, along with daytime use of the compression legging. The other half (the control group) will use the compression leggings only. At the third visit, final measurements will be obtained. The measurements in the study include volume measurements using tape measure and a scanner; body composition measurements (bioimpedance); ultrasound and biopsy of the skin; timed walking and gait measurements; and questionnaires about pain and quality of life. Deidentified (without names) patient medical records will be examined for information on vein disease, body mass index, weight, age, and stage of lipedema (any stage or type). After the third visit, results will be analyzed.

Primary Outcome Measures: ultrasound assessment of adipose tissue deposits, ultrasound of lower extremities and hips to assess fascia, echogenicity and depth. The integrity and quality of SAT superficial and deep fascia layers will be assessed by visual analogue scale analysis of ultrasound images by three independent reviewers. Images from a previous study will be used to create a 5-point scale of fascia quality(16, 23) which the reviewers will use to assess fascia quality from tissue ultrasounds obtained from our study subjects. SAT fibrosis will be measured by:

1. Echogenicity of SAT and muscle.
2. Tissue Rigidity Assessment, 30 days|tissue volume assessed by tape measure, leg volume assessed by circumferential measurements every 10 cm to upper thigh using Jobst measuring board; waist measurements assessed with vertical measurement to the umbilicus and waist and hip circumferential measurements according to WHO guidelines, 30 days|Volumetric measurement, Volumetric measurement of lower torso and legs using a validated handheld three dimensional scanning device (Lymphatech Company), 30 days|Volumetric measurements by caliper, caliper measurements under the umbilicus, on the anterior thigh and medial thighs previously measured in women with lipedema, 30 days|Tissue/fluid assessment by bioimpedance analysis, Leg and trunk fluid volume measured by bioimpedance analyses, 30 days|Pain measured using visual analog scale, Leg pain measured by Visual Analog Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')., 30 days|Quality of life questionnaire, Quality of life measured by validated questionnaire RAND 36-item Health Survey 1.0 (SF-36), 30 days|Lower extremity functional scale (LEFS), he Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The scale for each question is 0 - 4, with 0 = extreme difficulty and 4 = no difficulty. The lower the score the greater the disability.

* The minimal detectable change is 9 scale points.
* The minimal clinically important difference is 9 scale points.
* % of maximal function = (LEFS score) / 80 \* 10, 30 days
Secondary Outcome Measures: Skin biopsy- presence of perpendicularly oriented blood vessels, Assessment of improvement in microvascular structure by skin biopsy. : Skin biopsies have previously shown that blood vessels in the dermis of lipedema patients are oriented in a perpendicular manner indicative of inflammation. The percentage of perpendicularly oriented blood vessels in each biopsy sample will be counted., 30 days|Thermography, We will assess changes in tissue microvasculature after use of the Lympha Press Optimal Plus with Lympha Pants by thermography photos (FLIR) of the legs and hypothesize a decrease in the overall number of visible vessels. The room temperature must be constant for repeat measurements. Non-thermogenic (regular) photos will also be taken in case body contours need to be assessed to determine locations of brighter spots in the photos representing dilated blood vessels., 30 days|Improvement in mobility as measured by Timed Up and Go (TUG) test, Timed Up and Go test (TUG) measures the time in seconds it takes for the subject to rise from a sitting position, walk 10 feet at a normal pace, turn around, walk back to the chair and sit down. We anticipate that use of the Lympha Press Optimal Plus will reduce (in seconds) the time it takes each subject to perform this test., 30 days|Chart review - enlarged veins, We will review the patient's clinic medical records for presence or absence of enlarged veins. No protected health information will be retrieved., 30 days|Improvement in mobility as measured by the Gait-Rite device, The GAITRite® system automates measuring temporal (timing) and spatial (distance) gait parameters (temporal/spatial) and 8 levels of relative pressure. Measurements of each subject will be taken to determine if treatment with the Lympha Press Optimal Plus changes gait as measured in step length, stride length, step width and foot angle., 30 days|Chart review for vein disease, We will review the patients' clinic medical records for presence or absence of venous disease. No protected health information will be retrieved., 30 days