5 Participants NeededMy employer runs this trial

Advanced Pneumatic Compression for Lymphedema

SV
Overseen BySenior Vice President Marketing and Market Access
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using a compression device to assist individuals with lower body lymphedema, a condition where fluid accumulates and causes swelling. The goal is to determine if this method improves lymph movement, a fluid that helps fight infections, through the body. Individuals with active lower leg lymphedema who are already using or can use a compression device might be suitable candidates. The study aims to assess whether the revised compression method, utilizing an advanced pneumatic compression device (APCD) with updated compression programming, outperforms the current method. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to experience this innovative approach.

What prior data suggests that this advanced pneumatic compression device is safe for lymphedema?

Research shows that the advanced pneumatic compression device (APCD) is generally easy to use without issues. In earlier studies, people using APCDs experienced better control of their lymphedema and reduced swelling. Specifically, data from 71 patients showed a significant decrease in limb swelling. These results suggest that APCDs not only alleviate symptoms but are also safe to use. Although this trial is in an early stage, providing limited detailed safety information, the general safety of APCDs in other studies is reassuring.12345

Why are researchers excited about this trial?

Researchers are excited about the advanced pneumatic compression device (APCD) because it brings a fresh approach to managing lymphedema. Unlike traditional compression garments or manual lymphatic drainage, the APCD features revised compression programming, which aims to provide more effective and personalized therapy. This device could offer enhanced lymphatic fluid movement, potentially reducing swelling and discomfort more efficiently than current options. By fine-tuning the pressure settings, the APCD might better mimic natural body rhythms, leading to improved patient outcomes and quality of life.

What evidence suggests that this advanced pneumatic compression device is effective for lymphedema?

Studies have shown that the advanced pneumatic compression device (APCD), used by participants in this trial, can significantly aid individuals with lymphedema. For example, it has been linked to noticeable improvements in managing swelling and reducing the size of affected limbs. In one study, patients reported better control over their condition and less visible swelling. Another study found that using the APCD improved limb movement and reduced the severity of symptoms. Overall, research suggests that these devices effectively relieve lymphedema symptoms.16789

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have active lymphedema in their legs and are suitable candidates for treatment with an advanced pneumatic compression device. Participants must be able to give consent and follow the study's requirements.

Inclusion Criteria

I am 18 years old or older.
Must be able to provide informed consent prior to study participation
I have active lymphedema in my legs.
See 2 more

Exclusion Criteria

Participant is pregnant or trying to become pregnant
I have severe soft tissue fibrosis in my skin or tissues.
I have severe artery disease causing pain, wounds, or gangrene in my limbs.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 60-minute treatment in clinic with the Advanced Pneumatic Compression Device (APCD) to evaluate lymphatic function

1 day
1 visit (in-person)

Follow-up

Participants are monitored for adverse events and changes in lymphatic function

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Advanced pneumatic compression device (APCD) with revised compression programming

Trial Overview

The study compares a standard advanced pneumatic compression device (APCD) to the same device with updated compression settings, aiming to see if the new method improves lymph flow. Indocyanine Green may be used to help track lymph movement.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment groupExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tactile Medical

Lead Sponsor

Trials
16
Recruited
1,200+

Citations

Pneumatic Compression Pumps for Treatment ...

The findings showed some improvements in patient-reported outcomes and swelling, although adherence was low, with only one patient using the device twice daily

Advanced pneumatic compression for treatment of ... - PMC

APCD use was associated with significant improvement in perceived ability to control lymphedema (p = 0.003) and visible external swelling (front view p < 0.001,

A multisite randomized trial of an advanced pneumatic ...

The primary outcome was improvement in lymphedema associated symptom severity. Additional outcomes included anatomical measures, patient ...

Compression Devices for Treatment of Lymphedema and ...

The findings showed some improvements in patient-reported outcomes and swelling, although adherence was low, with only one patient using the device twice daily

Results from a comparative study to evaluate the treatment ...

Key Findings: Data from 71 patients (108 affected limbs) with lower extremity lymphedema demonstrated significant greater improvements in limb edema and in ...

Results from a comparative study to evaluate the treatment ...

Data from 71 patients (108 affected limbs) with lower extremity lymphedema demonstrated significant greater improvements in limb edema

Effect of Advanced Pneumatic Compression Devices in the ...

The data showed consistent reduction of limb volume and improved patient-reported outcomes, indicating that APCDs are generally effective as ...

Safety and effectiveness of a novel nonpneumatic active ...

Compared with the APCD, the NPCD was associated with a greater mean reduction in the limb edema volume (64.6% vs 27.7%; P < .001), significantly. The results ...

effect of advanced pneumatic compression devices

The data showed consistent reduction of limb volume and improved patient-reported outcomes, indicating that APCDs are generally effective as a