Clinical Trial

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

Enrolling by Invitation Phase 1/2
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Record status
This record was last updated September 16, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-02.
Trial Details
NCT Number NCT07165340
Lead Sponsor The University of Texas Health Science Center, Houston
Collaborators: Tactile Medical
Conditions Chronic Venous Disease
Enrollment 34 participants
Start Date 2025-09
Primary Completion 2026-06 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-09-16