Effects of Intermittent Pneumatic Compression Therapy on Tissue Volume, Pain, and Quality of Life in Lipedema

Completed · Not applicable

Conditions studied: Lipedema

In brief

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.

Key facts

Study ID

NCT06549738

Run by

Lympha Press

People needed

46

Starts

2023-08-21

Expected to finish

2023-11-16

Last updated by the study team

2024-08-12

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females age 18 - 70 years.
• Diagnosis of Stage 2-3 Type II-III lipedema
• Patients with an IPCD must agree to wash off the pump over 30 days prior to the study starting.
• Must have pain score with or without pressure in any lipedema area of 3 or more out of 11-point Likert visual analogue scale.
• Able to maintain their current diet and exercise regimen for the 60-day study.
• Must be ambulatory.
• Must be willing to wear compression during the study. Compression is provided at no cost as part of the study.
• Consistent eating plan with weight stability (within 10 lbs or usual weight fluctuation per the patient) over three months.
• Must agree to not change their diet and exercise during the study.

You may not qualify if…

• Inability to understand the purpose of the study and complete consent.
• Bed bound, preventing assessment of activities of daily living like the rest of the population we are studying.
• Contraindications to IPCD use:
• serious arterial insufficiency measured as a monophasic pulse wave by Doppler
• edema due to decompensated congestive heart failure by history - all patients with a diagnosis of CHF will be excluded for purpose of the study
• active phlebitis by physical exam
• active deep vein thrombosis by history
• localized wound infection by physical exam
• cellulitis by physical exam
• Lymphedema with minimal to no lipedema.
• Positive Stemmer sign on the feet.
• Weight > 375 lbs. (170 kg) due to weight restriction on bioimpedance device.
• Undergoing surgery during the time of the study.
• Weight loss surgery within the past 18 months.
• Use of diuretic medication.
• Participation in another research study at the time of the study.
• Use of immunosuppressant medications including Gleevec, diosmin, methotrexate, corticosteroids, Plaquenil or other. If they are on these medications, they must wean off for one month or not participate in this study.
• Medical illness deemed significant by the PI.
• Waist to hip ratio > 0.85.
• Undergoing manual therapy of any kind including massage, physical therapy, occupational therapy, manual lymphatic drainage therapy, instrument assisted soft tissue therapy or other deep tissue therapy. Subjects must agree to stop all manual therapy for one month prior to participation in this study.

Where it is running

• Carolina Vein Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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