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Purpose

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?

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment group
  • Device: Advanced pneumatic compression device (APCD)
    Single APCD treatment session at visit 1
  • Device: Advanced pneumatic compression device (APCD) with revised compression programming
    APCD with revised compression programming will be single treatment session at visit 2
  • Drug: Indocyanine Green (IC-Green)
    Indocyanine Green dye will be used to assess primary endpoint

Recruiting Locations

UTHealth Houston (The University of Texas Health Science Center at Houston)
Houston, Texas 77030
Contact:
John Rasmussen, PhD
713-500-3393
John.Rasmussen@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
Tactile Medical

Study Contact

Senior Vice President Marketing and Market Access
1.833.382.2845
clinicalresearch@tactilemedical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.