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

NCT07165340 | Enrolling By Invitation Phase 1 FDA Drug FDA Device

• 1 other identifier: HSC-MS-25-0191
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

near-infrared fluorescence lymphatic imaging; lymphatic imaging; pneumatic compression therapy; indocyanine green; chronic venous disease

Outcome Measures

Primary Outcomes (2)

• Extent of Dermal Backflow

  The area of abnormal dermal lymphatic backflow in the leg.

  Assessed at Visit 1 and 2 (approximately 30 days apart)

• Lymphatic pumping rate

  Number of pumping events observed per minute assessed in the medial ankle.

  Assessed at Visit 1 and Visit 2 (approximately 30 days apart)

Secondary Outcomes (6)

• Correlation of CEAP score and lymphatic pumping rates

  Assessed at Visit 1 and 2 (approximately 30 days apart)

• Correlation of CEAP score with extent of dermal backflow

  Assessed at Visit 1 and 2 (approximately 30 days apart)

• Change in limb volume between arms.

  Assessed at Visit 1 and 2 (approximately 30 days apart)

• Change in LLIS score between arms

  Assessed at Visit 1 and 2 (approximately 30 days apart)

• Change in Venous Clinical Severity Score (VCSS) between arms

  Assessed at Visit 1 and 2 (approximately 30 days apart)

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Subjects will receive standard-of-care compression bandaging.

Combination Product: Indocyanine Green near infrared fluorescence imaging; Diagnostic Test: Duplex ultrasound; Device: compression wrap

Treatment Arm

EXPERIMENTAL

Subjects will receive both standard-of-care compression bandaging AND daily treatments with an advanced pneumatic compression device.

Combination Product: Indocyanine Green near infrared fluorescence imaging; Device: advanced pneumatic compression; Diagnostic Test: Duplex ultrasound; Device: compression wrap

Interventions

Indocyanine Green near infrared fluorescence imaging COMBINATION_PRODUCT

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.

Also known as: near-infrared fluorescence lymphatic imaging

Control Arm; Treatment Arm

advanced pneumatic compression DEVICE

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.

Treatment Arm

Duplex ultrasound DIAGNOSTIC_TEST

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

Control Arm; Treatment Arm

compression wrap DEVICE

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

Control Arm; Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Tactile Medical: collaborator

Study Sites (1)

University of Texas Health Science Center at Houston/UTPhysicians

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Ultrasonography, Doppler, Duplex; Compression Bandages

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Bandages; Equipment and Supplies

Study Officials

• John C Rasmussen, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a blinded, prospective, 2-arm, randomized study.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)