Advanced Pneumatic Compression for Chronic Venous Disease

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Cancer, Heart failure, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4-6 weeks

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

John C Rasmussen, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for patients with chronic venous disease, specifically those who have not yet received treatment and are classified as CEAP C3 or C4. Participants should be willing to undergo daily pneumatic compression therapy at home if placed in the treated group, alongside standard compression bandaging.

Inclusion Criteria

I am over 18 years old.

Participant must provide informed consent

Participant must be willing and able to fulfill study timeline

Exclusion Criteria

I have a blockage in a deep vein.

My skin condition is not caused by cardiovascular disease.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive advanced pneumatic compression therapy and standard-of-care compression bandaging for 30-45 days

4-6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in lymphatic and venous function after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Advanced Pneumatic Compression

Trial Overview The study compares two groups of patients: one receiving standard care plus advanced pneumatic compression therapy, and a control group getting only standard care. It aims to see if the additional treatment improves lymphatic function over approximately 30-45 days.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 4 Interventions

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

Group II: Control Arm Active Control 3 Interventions

Subjects will receive standard-of-care compression bandaging.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Tactile Medical

Industry Sponsor

Trials

16

Recruited

1,200+