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

Enrolling by invitation · Phase 1/Phase 2

Conditions studied: Chronic Venous Disease

In brief

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.

Key facts

Study ID

NCT07165340

Run by

The University of Texas Health Science Center, Houston

People needed

34

Starts

2025-09-01

Expected to finish

2026-08-01

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant >18 years of age
• Participant with an objective diagnosis of CEAP Class 3 or 4 superficial venous disease (superficial reflux time >0.5 sec), with venous edema (revised VCSS score of 2 or 3 for edema).
• Participant must provide informed consent
• Participant is willing and able to fulfill study timeline
• Participant is a candidate for APCD treatment per the FTP indications
• Lymphatic dysfunction is observed, using NIRF-LI, in affected limb.

You may not qualify if…

• History of pelvic or lower extremity cancers
• Systemic organ failure including heart failure
• BMI >35
• Previous endovascular or open vascular interventions
• Patients with known, or family history of, primary lymphedema
• Prior use of advanced pneumatic compression device, or complete decongestive therapy (CDT) on the lower extremities
• Peripheral arterial disease with ABI <0.8
• Participants with deep venous obstruction
• Skin disease not related to CVD
• Participants with iodine allergies including patients with shellfish allergy who may be allergic to iodine that may be in the ICG formulation
• Females who are pregnant or breastfeeding
• Females with the intent of becoming pregnant within 30 days after participation in final imaging session

Where it is running

• University of Texas Health Science Center at Houston/UTPhysicians — Houston, Texas, United States

Full record on ClinicalTrials.gov

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