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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how advanced pneumatic compression (a therapy using air pressure to improve circulation) can assist individuals with certain types of chronic venous disease. It aims to determine if this therapy can enhance the lymphatic system's function, which helps clear waste and fluids. Participants will receive either standard compression bandaging or additional at-home pneumatic compression treatments. The study seeks individuals diagnosed with CEAP Class 3 or 4 venous disease who experience leg swelling. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this advanced pneumatic compression device is safe for treating chronic venous disease?

Research has shown that advanced pneumatic compression is generally safe for treating chronic venous disease. In a previous study, researchers used this device to reduce swelling in the legs of individuals with lower limb problems, finding it both safe and effective. Another study focused on patients with more severe chronic venous disease and found that the device can improve health outcomes, such as reducing leg swelling.

While these studies show promising safety results, this trial remains in its early stages, so there may not be extensive information on long-term safety yet. However, the device is similar to other compression therapies that have been used safely for a long time. It is important to consult a healthcare provider if there are concerns about safety when considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about advanced pneumatic compression for chronic venous disease because it offers a new approach to managing the condition. Unlike the standard of care, which typically involves compression bandaging alone, this treatment combines traditional methods with an advanced pneumatic compression device. This device provides dynamic, targeted pressure, potentially improving blood flow and reducing symptoms more effectively. By enhancing the efficiency of compression therapy, this innovative method could lead to better patient outcomes and improved quality of life.

What evidence suggests that advanced pneumatic compression is effective for chronic venous disease?

Research has shown that advanced pneumatic compression devices (APCDs) effectively treat lower extremity lymphedema, a condition where excess fluid causes leg swelling. Studies have found that these devices reduce swelling and improve blood flow in individuals with chronic venous disease. In this trial, participants in the treatment arm will receive both standard-of-care compression bandaging and daily treatments with an advanced pneumatic compression device. Patients using these devices at home experienced significant health benefits, such as reduced swelling and improved movement. One study highlighted positive outcomes for patients with chronic venous insufficiency (CVI), where APCDs improved the underlying causes of the disease. Overall, these devices have shown promising results in enhancing symptoms and quality of life for people with related conditions. ^{1 2 3 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11764854/

Results from a comparative study to evaluate the treatment ... Advanced pneumatic compression devices (APCDs) have been shown to be effective in treatment of lower extremity lymphedema in the home setting.

2. jvsvenous.org jvsvenous.org/article/S2213-333X(17)30266-4/fulltext

Patient-centered outcomes of a dual action pneumatic ... This is the first trial comparing an adaptive pneumatic compression device with CS in previously noncompliant patients with C3 to C6 chronic venous disease. The ...

3. jvascsurg.org jvascsurg.org/article/S0741-5214(02)75244-0/fulltext

A systematic review of pneumatic compression for ... In this model, pneumatic pumps affect the physiologic processes underlying CVI and venous ulcers, leading to beneficial health outcomes such as reduced edema, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509624004114

Patient-Centered Outcomes of a Lymphedema Pump in ... This study aims to evaluate patient-reported outcomes of an advanced pneumatic compression device (APCD) in the treatment of lower extremity phlebolymphedema.

5. annphlebology.org annphlebology.org/journal/view.html?uid=174&vmd=Full

Is Compression Therapy Becoming Increasingly Worthless? Emerging studies have suggested that compression therapy continues to provide significant benefits, particularly in patients with advanced chronic venous ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509624004515

Clinical Guidelines on Compression Therapy in Venous ... Compression therapy is a form of physical therapy that uses devices to exert continuous or intermittent pressure or suction on specific areas of the body.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02395302

Evaluation of a Dual Action Pneumatic Compression ... The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression ...