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

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

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?

Study Overview

• Status: Recruiting
• Conditions: Lower Extremity Lymphedema
• Intervention / Treatment: Device: Advanced pneumatic compression device (APCD); Device: Advanced pneumatic compression device (APCD) with revised compression programming; Drug: Indocyanine Green (IC-Green)

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Senior Vice President Marketing and Market Access; Phone Number: 1.833.382.2845; Email: clinicalresearch@tactilemedical.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • UTHealth Houston (The University of Texas Health Science Center at Houston)
      • Contact: John Rasmussen, PhD; Phone Number: 713-500-3393; Email: John.Rasmussen@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphatic anatomy	• The distance (cm) that lymph travels from injection sites	Before and after 60-minute treatment in clinic with APCD
Lymphatic propulsion	• Number of lymph propulsion events per minute	Before and after 60-minute treatment in clinic with APCD

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate swelling in treatment limbs	• Changes in leg circumferential measurements (cm)	Before and after 60-minute treatment in clinic with APCD
Evaluate swelling in treatment limbs	Change in local water content (ratio of % water content in legs to reference site)	Before and after 60-minute treatment in clinic with APCD
Adverse Events	• Adverse Event assessments	Through completion of study at Visit 2, up to 4 weeks

Collaborators and Investigators

• Sponsor: Tactile Medical

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 9, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: lymphedema; lower extremity
• Additional Relevant MeSH Terms: Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphedema; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indocyanine Green
• Other Study ID Numbers: 7010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes