Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07613931

Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment

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?

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UTHealth Houston (The University of Texas Health Science Center at Houston)

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

John Rasmussen, PhD

CONTACT

[email protected]

713-500-3393

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • A diagnosis of active lower extremity lymphedema, as assessed by medical history
  • Participant is a candidate for APCD treatment per the Flexitouch Plus indications for use
  • Must be able to provide informed consent prior to study participation
  • Willing and able to comply with the study protocol requirements and all study-related visit requirements

Exclusion criteria

  • Heart failure (acute pulmonary edema, decompensated acute heart failure)
  • Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
  • Severe peripheral artery disease (critical limb ischemia, including ischemic rest pain, arterial wounds or gangrene)
  • Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the trunk or lower extremities
  • Active cancer or metastasis in the lower extremity lymphatic watersheds
  • Eczema, rash, scarring, or extensive tattoos at imaging sites
  • Participant is pregnant or trying to become pregnant
  • Participants with a history of allergy to iodides, who may be susceptible to iodine present in ICG formulation
  • Patients exhibiting Grade 3 or higher on the CTCAE v6.0 superficial soft tissue fibrosis scale
  • Body Mass Index (BMI) ≥40
  • 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

Treatment and study plan

Advanced Pneumatic Compression Device (APCD)

Device

Single APCD treatment session at visit 1

Advanced pneumatic compression device (APCD) with revised compression programming

Device

APCD with revised compression programming will be single treatment session at visit 2

Indocyanine Green (IC-Green)

Drug

Indocyanine Green dye will be used to assess primary endpoint

Primary outcomes

  1. Lymphatic anatomy

    Time frame: Before and after 60-minute treatment in clinic with APCD

    • The distance (cm) that lymph travels from injection sites
  2. Lymphatic propulsion

    Time frame: Before and after 60-minute treatment in clinic with APCD

    • Number of lymph propulsion events per minute

Secondary outcomes

  1. Evaluate swelling in treatment limbs

    Time frame: Before and after 60-minute treatment in clinic with APCD

    • Changes in leg circumferential measurements (cm)
  2. Evaluate swelling in treatment limbs

    Time frame: Before and after 60-minute treatment in clinic with APCD

    Change in local water content (ratio of % water content in legs to reference site)

  3. Adverse Events

    Time frame: Through completion of study at Visit 2, up to 4 weeks

    • Adverse Event assessments

Study contacts

Contact information is provided by the study sponsor or research team.

Senior Vice President Marketing and Market Access

CONTACT

[email protected]

1.833.382.2845

Sponsors and collaborators

Lead sponsor

Tactile Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.