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Enrolling by Invitation

NCT Number: NCT07165340

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

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.

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Key information

Conditions

Chronic Venous Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Texas Health Science Center at Houston/UTPhysicians

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: near-infrared fluorescence lymphatic imaging

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.

Duplex ultrasound

Diagnostic Test

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

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).

Primary outcomes

  1. Extent of Dermal Backflow

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

    The area of abnormal dermal lymphatic backflow in the leg.

  2. Lymphatic pumping rate

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

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

Secondary outcomes

  1. Correlation of CEAP score and lymphatic pumping rates

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

  2. Correlation of CEAP score with extent of dermal backflow

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

  3. Change in limb volume between arms.

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

    Limb volume, determined from limb circumference measurements, will be assessed at both visits.

  4. Change in LLIS score between arms

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

    Patient reported outcomes assessed using the Lymphedema Life Impact Scale (LLIS) at each visit and change determined after Visit 2. Possible scores range from 0 to 100 with a higher score indicating a greater impact of disease on quality of life.

  5. Change in Venous Clinical Severity Score (VCSS) between arms

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

    Venous Clinical Severity Score (VCSS) will be assessed at each visit. Possible scores range from 0 to 30 with a higher score indicating a greater severity of vascular disease.

  6. Change in patient reported outcomes between arms

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

    Patient reported outcomes assessed using the Lower Extremity Functional Scale (LEFS) at each visit and change determined after Visit 2. Possible scores range from 0 to 80 with a higher score indicating a greater impact of disease on limb functionality.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Tactile Medical

Registry information

Official study title

Evaluation of Lymphatic Response to Treatment in Patients With Edema Secondary to Superficial Venous Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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