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Chronic Venous DiseasePhase 1/2NCT07165340

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

A Phase 1/2 study testing Indocyanine Green near infrared fluorescence imaging, advanced pneumatic compression and Duplex ultrasound in people with Chronic Venous Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Venous Disease
What is being tested?
Indocyanine Green near infrared fluorescence imaging, advanced pneumatic compression and Duplex ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
Sep 2025to Aug 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of Texas Health Science Center at Houston/UTPhysicians

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Evaluation of Lymphatic Response to Treatment in Patients With Edema Secondary to 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.
Being tested
Indocyanine Green near infrared fluorescence imaging, advanced pneumatic compression, Duplex ultrasound, compression wrap
Keywords
near-infrared fluorescence lymphatic imaging, lymphatic imaging, pneumatic compression therapy, indocyanine green, chronic venous disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine Green near infrared fluorescence imagingCombination product

    Also called near-infrared fluorescence lymphatic 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 compressionDevice

    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 ultrasoundDiagnostic test

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

  • compression wrapDevice

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

Study groups in NCT07165340
Study groupRoleWhat they receive
Control ArmActive comparatorSubjects will receive standard-of-care compression bandaging.
Receives: Combination Product: Indocyanine Green near infrared fluorescence imaging; Diagnostic Test: Duplex ultrasound; Device: compression wrap
Treatment ArmExperimentalSubjects will receive both standard-of-care compression bandaging AND daily treatments with an advanced pneumatic compression device.
Receives: Combination Product: Indocyanine Green near infrared fluorescence imaging; Device: advanced pneumatic compression; Diagnostic Test: Duplex ultrasound; Device: compression wrap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extent of Dermal Backflow

    The area of abnormal dermal lymphatic backflow in the leg.

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

  2. Lymphatic pumping rate

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

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

Secondary outcomes (6)

  1. Correlation of CEAP score and lymphatic pumping rates

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

  2. Correlation of CEAP score with extent of dermal backflow

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

  3. Change in limb volume between arms.

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

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

  4. Change in LLIS score between arms

    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.

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

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

    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.

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

  6. Change in patient reported outcomes between arms

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a blinded, prospective, 2-arm, randomized study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07165340
Sponsor's protocol ID
HSC-MS-25-0191
Status last verified
Sep 2025
First submitted
19 Aug 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No: Results will be published in a scientific journal along with description of protocol. The complete data set includes large (GBs) sequences of images that may include protected health information (tattoos). Partial, redacted data sets may be sharable upon request.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Indocyanine Green near infrared fluorescence imaging, advanced pneumatic compression and Duplex ultrasound in people with Chronic Venous Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of Dermal Backflow (time frame: Assessed at Visit 1 and 2 (approximately 30 days apart)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07165340.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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