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

NCT06549738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-08-12

No results posted yet for this study

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.

Conditions

  • Lipedema

Interventions

DEVICE

Intermittent pneumatic compression therapy

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.

Sponsors & Collaborators

  • Carolina Vein Center

    collaborator UNKNOWN

  • Lympha Press

    lead OTHER

Principal Investigators

  • Karen L Herbst, MD, PhD · The Roxbury Institute

  • Lynda McHutchison · Carolina Vein Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2023-11-16
Completion
2023-11-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549738 on ClinicalTrials.gov