CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Intermittent pneumatic compression therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06549738
NCT06549738N/ACompleted

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

Lympha Press·interventional·Posted Aug 12, 2024·Updated Aug 12, 2024

In Brief

A clinical study evaluating Intermittent pneumatic compression therapy for Lipedema. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLipedema
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedAug 12, 2024
Enrollment StartAug 21, 2023
Primary CompletionNov 16, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 1.9 years ago

Interventions

Intermittent pneumatic compression therapydevice

Lympha Press Optimal Plus is an advanced intermittent pneumatic compression therapy device. It is FDA cleared (K170658) for the indication of lipedema as well as for other indications for use.