Status:
COMPLETED
Effects of Intermittent Pneumatic Compression Therapy on Tissue Volume, Pain, and Quality of Life in Lipedema
Lead Sponsor:
Lympha Press
Collaborating Sponsors:
Carolina Vein Center
Conditions:
Lipedema
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 lip...
Detailed Description
Introduction Lipedema is a disease of loose connective (adipose) tissue that has no known cause or cure. One of the main features is an increased amount of abnormal fibrotic subcutaneous adipose tissu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06549738
Start Date
August 21 2023
End Date
November 16 2023
Last Update
August 12 2024
Active Locations (1)
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1
Carolina Vein Center
Durham, North Carolina, United States, 27713