Evaluation of Lymphatic Response to Physiotherapy in Patients With Swelling Associated With Superficial Venous Disease

PHASE1/PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

August 31, 2026

Conditions
Chronic Venous Disease
Interventions
COMBINATION_PRODUCT

Indocyanine Green near infrared fluorescence imaging

A total of 10 intradermal injections of 25 ug indocyanine green (ICG) in 0.1 mL saline are administered in the feet, medial ankles, lateral calves, and thigh. The total dose of ICG will not exceed 250 ug. After injection, the legs will be illuminated by the dim output of a 780 nm laser diode, and the resultant fluorescent signal emanating from ICG-laden lymph will be collected by a custom built near-infrared fluorescent lymphatic imager.

DEVICE

advanced pneumatic compression

The advanced pneumatic compression device (APCD) mimics manual lymphatic drainage, a light massage that stimulates lymphatic uptake and function and frequently prescribed for lymphedema therapy. Daily treatment will be prescribed for approximately 30 days.

DIAGNOSTIC_TEST

Duplex ultrasound

Duplex ultrasound to measure venous reflux will be done at each visit.

DEVICE

compression wrap

A compression wrap, to provide 20-40 mm Hg of pressure, will be provided for daily use between visits (approximately 30 days).

Trial Locations (1)

77030

University of Texas Health Science Center at Houston/UTPhysicians, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Tactile Medical

INDUSTRY

lead

The University of Texas Health Science Center, Houston

OTHER

NCT07165340 - Evaluation of Lymphatic Response to Physiotherapy in Patients With Swelling Associated With Superficial Venous Disease | Biotech Hunter | Biotech Hunter