Evaluation of Lymphatic Response to Physiotherapy in Patients With Swelling Associated With Superficial Venous Disease
NCT ID: NCT07165340
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2025-09-30
2026-08-31
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control Arm
Subjects will receive standard-of-care compression bandaging.
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.
Duplex ultrasound
Duplex ultrasound to measure venous reflux will be done at each visit.
compression wrap
A compression wrap, to provide 20-40 mm Hg of pressure, will be provided for daily use between visits (approximately 30 days).
Treatment Arm
Subjects will receive both standard-of-care compression bandaging AND daily treatments with an advanced pneumatic compression device.
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.
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.
Duplex ultrasound
Duplex ultrasound to measure venous reflux will be done at each visit.
compression wrap
A compression wrap, to provide 20-40 mm Hg of pressure, will be provided for daily use between visits (approximately 30 days).
Interventions
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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.
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.
Duplex ultrasound
Duplex ultrasound to measure venous reflux will be done at each visit.
compression wrap
A compression wrap, to provide 20-40 mm Hg of pressure, will be provided for daily use between visits (approximately 30 days).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Participant must provide informed consent
4. Participant is willing and able to fulfill study timeline
5. Participant is a candidate for APCD treatment per the FTP indications
6. Lymphatic dysfunction is observed, using NIRF-LI, in affected limb.
Exclusion Criteria
2. Systemic organ failure including heart failure
3. BMI \>35
4. Previous endovascular or open vascular interventions
5. Patients with known, or family history of, primary lymphedema
6. Prior use of advanced pneumatic compression device, or complete decongestive therapy (CDT) on the lower extremities
7. Peripheral arterial disease with ABI \<0.8
8. Participants with deep venous obstruction
9. Skin disease not related to CVD
10. Participants with iodine allergies including patients with shellfish allergy who may be allergic to iodine that may be in the ICG formulation
11. Females who are pregnant or breastfeeding
12. Females with the intent of becoming pregnant within 30 days after participation in final imaging session
18 Years
ALL
No
Sponsors
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Tactile Medical
INDUSTRY
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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John Rasmussen
Associate Professor
Principal Investigators
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John C Rasmussen, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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University of Texas Health Science Center at Houston/UTPhysicians
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-25-0191
Identifier Type: -
Identifier Source: org_study_id
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