The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
Flexitouch Plus full arm and core treatment
Flexitouch Plus full arm and trunk/chest treatment
University of Texas Health Science Center at Houston
Houston, Texas, United States
Lymphatic Activation
Comparison of the change in the rate of lymphatic propulsion events from the pre-treatment values to the post-treatment values for both the affected and contralateral limbs using the investigational technique of near infrared-fluorescent (NIRF) imaging.
Time frame: Baseline and following a single treatment, an average of one hour
Changes in Swelling - MoistureMeterD
Comparison of the percent change in local tissue water from the pre-treatment values to the post-treatment values on the affected limb using MoistureMeterD.
Time frame: Baseline and following a single treatment, an average of one hour
Changes in Swelling - Perometry
Swelling in the affected and contralateral limb as assessed using local tissue water content
Time frame: Baseline and following a single treatment, an average of one hour
Percent Change in Skin Thickness From Baseline to After Treatment.
Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Time frame: Baseline and following a single treatment, an average of one hour
Incidence of Adverse Events
Adverse events reported between treatment and the 24-hour follow-up
Time frame: 24-Hour Follow-Up
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
Time frame: Baseline and following a single treatment, an average of one hour
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
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Comparison of the change in dermal backflow from the pre-treatment values to the post-treatment values as the sum of the volume of area for all locations for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging
Time frame: Baseline and following a single treatment, an average of one hour
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)
Time frame: Baseline and following a single treatment, an average of one hour
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
Comparison of the percent of participants by arm demonstrating a decrease in thickness for each site, separating skin and subcutaneous changes, on the affected limb via Ultrasound
Time frame: Baseline and following a single treatment, an average of one hour
Absolute Change in Skin Thickness From Baseline to After Treatment
Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Time frame: Baseline and following a single treatment, an average of one hour.