A Pilot Study to Evaluate and Compare Lymphatic Transport in Patients With Lower Extremity Lymphedema Between Flexitouch Plus® and Flexitouch Plus® With Novel Multi-Chamber Firmware
Tactile Medical
Summary
The goal of this pilot study is to learn if a revised method of compression improves lymphatic function compared to the current method of compression. The main questions: • Does the revised method of compression improve lymph movement and lymphatic propulsion?
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 18 years of age or older 2. A diagnosis of active lower extremity lymphedema, as assessed by medical history 3. Participant is a candidate for APCD treatment per the Flexitouch Plus indications for use 4. Must be able to provide informed consent prior to study participation 5. Willing and able to comply with the study protocol requirements and all study-related visit requirements Exclusion Criteria: 1. Heart failure (acute pulmonary edema, decompensated acute heart failure) 2. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary…
Interventions
- DeviceAdvanced pneumatic compression device (APCD)
Single APCD treatment session at visit 1
- DeviceAdvanced pneumatic compression device (APCD) with revised compression programming
APCD with revised compression programming will be single treatment session at visit 2
- DrugIndocyanine Green (IC-Green)
Indocyanine Green dye will be used to assess primary endpoint
Location
- UTHealth Houston (The University of Texas Health Science Center at Houston)Houston, Texas