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

NCT06549738 | Completed FDA Device

• 1 other identifier: PMM0089
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lipedema; lipoedema

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Skin biopsy- presence of perpendicularly oriented blood vessels

  30 days

• Thermography

  30 days

• Improvement in mobility as measured by Timed Up and Go (TUG) test

  30 days

• Chart review - enlarged veins

  30 days

• Improvement in mobility as measured by the Gait-Rite device

  30 days

Study Arms (2)

Treatment

EXPERIMENTAL

Lympha Press Treatment. While the first IPCD treatment takes place in Visit 2, subjects will be educated on the use of the IPCD and the protocol they will follow for the home treatment phase. During the hour-long treatment session in the clinic, the pressure will be gradually increased per subject tolerance starting at 20 mm Hg. Subjects will be instructed to use the IPCD at home for 1-2 hours a day, with pressure set to patient tolerance (recommended setting of 45 mmHg). In addition to IPCD treatment, subjects will be provided compression leggings at Visit 1 and instructed to wear them daily during all waking hours until Visit 3.

Device: Intermittent pneumatic compression therapy

Control

NO INTERVENTION

Subjects will be provided compression leggings at Visit 1 and instructed to wear them daily during all waking hours until Visit 3.

Interventions

Intermittent pneumatic compression therapy DEVICE

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.

Also known as: Lympha Press, Lympha Press Optimal Plus, HCPCS code E0652, pneumatic compression, lymphedema pump

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Lympha Press: lead
• Carolina Vein Center: collaborator

Study Sites (1)

Carolina Vein Center

Durham, North Carolina, 27713, United States

Location

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MeSH Terms

Conditions

Lipedema

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Karen L Herbst, MD, PhD

  The Roxbury Institute

  STUDY CHAIR

• Lynda McHutchison

  Carolina Vein Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled study planned for 50 women with lipedema with half (25) women in the Treatment group and half (25) women in the Control group. Both legs of all enrolled women will be studied for a total of 100 legs evaluated. All participants in the Treatment group will be supplied the Lympha Press Optimal Plus IPCD and the Lympha Pants™ garment to treat the lower body including the abdomen, pelvis, and buttocks (trunk) and the lower extremities. All participants in the study (Treatment and Controls) will receive compression leggings, and will be instructed to wear them daily.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 12, 2024
• Study Start: August 21, 2023
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)