Lower Extremity Lymphedema
Conditions
Keywords
lymphedema, lower extremity
Brief 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?
Interventions
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
Indocyanine Green dye will be used to assess primary endpoint
Sponsors
Tactile Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 embolism) 3. Severe peripheral artery disease (critical limb ischemia, including ischemic rest pain, arterial wounds or gangrene) 4. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the trunk or lower extremities 5. Active cancer or metastasis in the lower extremity lymphatic watersheds 6. Eczema, rash, scarring, or extensive tattoos at imaging sites 7. Participant is pregnant or trying to become pregnant 8. Participants with a history of allergy to iodides, who may be susceptible to iodine present in ICG formulation 9. Patients exhibiting Grade 3 or higher on the CTCAE v6.0 superficial soft tissue fibrosis scale 10. Body Mass Index (BMI) ≥40 11. Participants unable to recline on their backs for up to 60 consecutive minutes and walk in place or tolerate assisted lower extremity movement for 5 minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymphatic anatomy | Before and after 60-minute treatment in clinic with APCD | • The distance (cm) that lymph travels from injection sites |
| Lymphatic propulsion | Before and after 60-minute treatment in clinic with APCD | • Number of lymph propulsion events per minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate swelling in treatment limbs | Before and after 60-minute treatment in clinic with APCD | • Changes in leg circumferential measurements (cm) |
| Adverse Events | Through completion of study at Visit 2, up to 4 weeks | • Adverse Event assessments |
Countries
United States
Contacts
CONTACTSenior Vice President Marketing and Market Access
Outcome results
None listed