Complete Decongestive Therapy With Negative Pressure for Lipedema and Lymphedema Therapy

This study will assess the treatment impact of complete decongestive therapy (CDT) in
conjunction with negative pressure application using PhysioTouch (R) in women with lipedema
or secondary lymphedema. Lipedema is an adipose tissue disorder in which persons experience
pain and swelling in their legs and lower quadrants. Lipedema is a disorder that almost
exclusively effects females, is frequently inherited, and is triggered by hormonal changes.
Symptomatology includes symmetric swelling of the hypodermis of the legs, indentations in the
fat causing uneven skin which may include large extruding mounds of tissue, is often
accompanied by lymphedema, and is unresponsive to diet or exercise.

Women with secondary limb lymphedema in this study are persons who have developed lymphedema
following cancer treatment. Persons with lymphedema or lipedema often receive CDT. CDT is a
common conservative treatment to optimize lymphatic functioning using exercise, compression,
lymphatic stimulation and skin care. An adjunct component of therapy is the use of gentle
graded negative pressure to further enhance lymphatic stimulation. PhysioTouch is a gentle
graded negative pressure device designed to enhance lymphatic stimulation.

The investigators will evaluate to what extent CDT with graded negative pressure impacts
lymphatic functioning in patients with lipedema or lymphedema of the lower extremities.
Additionally, the investigators will also noninvasively evaluate lymphatic function using
Magnetic Resonance (MR) lymphangiography without contrast, and whether tissue sodium and fat
composition are associated with reduced lymphatic pumping dynamics in the study's group
cohorts. This will provide new information on the mechanism of dysfunctional fat clearance in
patients with lipedema using traditional conservative therapy. By outlining internal
mechanisms underlying lipedema etiology, and their response to CDT, this will provide
objective markers elucidating the unique characteristics of lipedema compared with secondary
lymphedema.

Study hypothesis: Therapeutic manipulation of lymphatic stasis over six weeks increases
lymphatic pumping kinetics and reduces tissue sodium accumulation.

Biophysical measurements will also be acquired, including bioimpedance spectroscopy and
perometry. Three cohorts will be studied: age-, gender-, and BMI-matched study controls,
patients with lipedema, and patients with secondary unilateral leg lymphedema from cancer
therapies. Only females will be recruited since lipedema primarily affects females. Only
patients with leg lymphedema following cancer therapies will be recruited to control for the
known reason for leg lymphedema. Subjects will be recruited from age 14 years and older since
lipedema is triggered by hormonal changes occurring with menarche and pregnancy. Measurements
will be repeated on a separate study date in a subset of volunteers. Reproducibility will be
determined using an intraclass correlation coefficient; results will establish the normative
range of these measures in healthy tissue. Significant differences in imaging metrics and
biophysical measures between groups will be evaluated using a one-way ANOVA. This work will
improve the investigators understanding of the physiology of lipedema compared to obesity and
lymphedema. The results will determine the potential for these measures to serve as
biomarkers of lipedema, as distinguished from obesity or on a spectrum of lymphedema. The
results will also evaluate for changes in lymphatic pumping and tissue sodium accumulation
following a commonly used physical therapy intervention over a course of 6 weeks in the two
patient populations, lipedema (n=5) and secondary leg lymphedema (n=5).

Inclusion Criteria:

- Females with a diagnosis of lipedema or a probable diagnosis of lipedema

- Females with a diagnosis of secondary limb lymphedema following cancer treatments

Exclusion Criteria:

- 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).