Recruiting
Early Phase 1

Compression Method

Sponsor:

Tactile Medical

Code:

NCT07613931

Conditions

Lower Extremity Lymphedema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Advanced pneumatic compression device (APCD)

Advanced pneumatic compression device (APCD) with revised compression programming

Indocyanine Green (IC-Green)

Study Details

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?

Conditions

Lower Extremity Lymphedema

Study ID

NCT07613931

Start date

Jul 9, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Treatment group

Interventions

Advanced pneumatic compression device (APCD)

Single APCD treatment session at visit 1

Advanced pneumatic compression device (APCD) with revised compression programming

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

Indocyanine Green (IC-Green)

Indocyanine Green dye will be used to assess primary endpoint

Primary outcome measure

  • Lymphatic anatomy [ Time Frame: Before and after 60-minute treatment in clinic with APCD ]
  • Lymphatic propulsion [ Time Frame: Before and after 60-minute treatment in clinic with APCD ]

Central Contacts and Locations

Central contacts

Senior Vice President Marketing and Market Access

1.833.382.2845clinicalresearch@tactilemedical.com

Locations

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

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Tactile Medical

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • lymphedema
  • lower extremity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tactile Medical on 2026-08-11.