Complete Decongestive Therapy With Negative Pressure for Lipedema and Lymphedema Therapy

Completed · Not applicable

Conditions studied: Lipedema, Secondary Lymphedema

In brief

This study is designed to investigate the therapy outcomes from routine physical therapy in persons with lipedema and secondary limb lymphedema. Complete decongestive therapy (CDT) is a common conservative treatment to optimize lymphatic functioning using exercise, compression, lymphatic stimulation and skin care. PhysioTouch is a gentle graded negative pressure device designed to enhance lymphatic stimulation that is used by the skilled therapist in conjunction with hands on techniques of tissue mobilization for enhanced clearance of lymph stasis in persons with lymphedema. This study will investigate the conservative treatment impact in patients with lipedema and lower extremity lymphedema using this conservative available technique.

Key facts

Study ID

NCT03634462

Run by

Vanderbilt University Medical Center

People needed

10

Starts

2019-01-15

Expected to finish

2020-02-28

Last updated by the study team

2020-05-19

Who can join

Age: 14 and older, up to 90. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Females with a diagnosis of lipedema or a probable diagnosis of lipedema
• Females with a diagnosis of secondary limb lymphedema following cancer treatments

You may not qualify if…

• Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.) or are not able to comfortably be able to tolerate the limited fit of the MRI
• Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
• Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
• Pregnant women will be excluded from the MRI portion of the study only
• Subjects who have open wounds on either ankle or top of foot because of contraindications with placement of electrodes to obtain the L-DEX U400 readings.
• Persons with heart pacemakers.
• Persons with Dercum's disease, diabetes or high blood pressure (systolic great than 140 and diastolic great than 90).

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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