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Pneumatic compression may unclog lymphatic system in leg swelling patients

NCT ID NCT07165340

Knowledge-focused Sponsor: The University of Texas Health Science Center, Houston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether a pneumatic compression device can improve lymphatic function in people with leg swelling from chronic venous disease. 34 participants will be split into two groups: one gets standard compression bandages, the other adds daily pneumatic compression at home. Researchers will use imaging to measure changes in lymphatic function and vein health over 30-45 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
advanced pneumatic compression device
What this could lead to
If successful, this could show that pneumatic compression improves lymphatic function, pointing toward better edema management.
What could go wrong
This is an early-phase study with only 34 participants, so results may not apply broadly. It measures short-term changes, not long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant \>18 years of age 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: 1. History of pelvic or lower extremity cancers 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

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic venous disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Texas Health Science Center at Houston/UTPhysicians

    Houston, Texas, 77030, United States

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