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Clinical Trials in the USA / NCT07613931
Recruiting Phase EARLY_PHASE1

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

NCT07613931 · tracked via the Priya Life Science USA tracker
Sponsor
Tactile Medical
Phase
Phase EARLY_PHASE1
Started
2026-07-09
Last updated
2026-08-11

Condition(s) studied

Lower Extremity Lymphedema

Investigational drug(s) / intervention(s)

Advanced pneumatic compression device (APCD)Advanced pneumatic compression device (APCD) with revised compression programmingIndocyanine Green (IC-Green) →

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

Study 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?

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
UTHealth Houston (The University of Texas Health Science Center at Houston) Houston Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07613931 on ClinicalTrials.gov ↗ ← All trials in the USA