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

Summary

This study seeks to demonstrate the effect of advanced pneumatic compression in treatment naïve patients with CEAP C3 and C4 chronic venous disease. The main questions it aims to answer are:

* Does lymphatic treatment improve lymphatic function following \~30 days of advanced pneumatic compression device therapy?
* Does lymphatic dysfunction correlate with CEAP score and venous reflux times? Over the course of 30-45 days, participants will undergo two sessions of near-infrared fluorescence lymphatic imaging to assess whether advanced pneumatic compression treatment improves lymphatic (dys)function. Subjects will be divided into two groups, a treated and a control group. Both groups will receive standard-of-care compression bandaging. The treated group will also be asked to complete daily sessions of pneumatic compression therapy at home. At both imaging sessions, duplex ultrasound will also be used to assess venous reflux times. Researchers will compare the changes in lymphatic and venous (dys)function between the two groups to see if lymphatic function improves with pneumatic compression treatment and if they dysfunction is correlated with CEAP clinical score and venous reflux times.

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).

Sponsors & Collaborators

• Tactile Medical

  collaborator INDUSTRY

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• John C Rasmussen, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2026-06-30

Completion

2026-08-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations