What side effects are associated with this type of intervention?

Common treatments for lymphedema, including Advanced Pneumatic Compression Devices (APCD), compression garments, manual lymphatic drainage (MLD), and complete decongestive therapy (CDT), generally have mild side effects. APCDs can cause discomfort, skin irritation, or bruising due to the mechanical pressure applied. Compression garments, if not properly fitted, can lead to skin irritation, restricted blood flow, or exacerbation of swelling. MLD is generally safe but may cause temporary discomfort or pain. CDT, which combines several therapies, may result in skin irritation, discomfort, or fatigue. Severe adverse events are rare across these treatments.

What prior FDA approvals exist?

The FDA has approved various treatments for lymphedema, including surgical options like lymphovenous bypass and lymph node transfer, which have shown significant improvements in limb volume and symptom relief. These procedures aim to enhance lymphatic drainage, similar to the Advanced Pneumatic Compression Device (APCD). While specific FDA approvals for devices like the APCD are not detailed, compression garments and pneumatic compression devices are commonly used and recommended for managing lymphedema.

What other types of research exist?

Promising, novel alternatives to the Advanced Pneumatic Compression Device (APCD) for lymphedema patients in 2024 may include devices that utilize phased compression techniques, similar to the Phased Compression Cardiac Assist Device (PCCAD). These devices could offer non-invasive, synchronized compression to enhance lymphatic drainage. Additionally, hybrid devices that combine mechanical support with biological agents, as seen in cardiac support devices, may also be explored for their potential to reduce fibrosis and improve lymphatic function.

← Back to Search

Pneumatic Compression Device

Advanced Pneumatic Compression Device for Lymphedema

N/A

Waitlist Available

Led By Barbara Murphy, MD

Research Sponsored by Tactile Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes between baseline, 2 months, 4 months, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the effectiveness of an air pressure device (APCD) to standard treatment in reducing swelling and improving quality of life for head and neck cancer survivors. The device works by gently massaging the swollen areas to help move excess fluid out of the tissues.

Who is the study for?

This trial is for English-speaking adults over 18 who've finished cancer treatment with no active cancer, have head and neck lymphedema diagnosed, and experience related symptoms. It's not for those previously treated for this condition, with acute facial infections, carotid sinus hypersensitivity, recent severe carotid artery disease events or internal jugular venous thrombosis.

What is being tested?

The study compares an Advanced Pneumatic Compression Device (APCD) to Usual Care in managing lymphedema and fibrosis in survivors of head and neck cancer. Participants will be randomly assigned to either the APCD group or receive standard care treatments.

What are the potential side effects?

Potential side effects from using the APCD may include discomfort at the site of application, skin irritation or bruising. The usual care might vary but generally includes low risks associated with non-invasive therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes between baseline, 2 months, 4 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes between baseline, 2 months, 4 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes between baseline, 2 months, 4 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body image - Body Image Quality of Life Inventory (BIQLI)

Diet modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)

Perceived self-management capacity - Perceived Medical Condition Self-Management Scale (PMCSMS)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Advanced Pneumatic Compression Device (APCD)Active Control1 Intervention

Daily self-administered treatment with the Flexitouch® Plus system (FT)

Group II: Usual CareActive Control1 Intervention

Complete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lymphedema treatments aim to reduce swelling and improve lymphatic drainage. Advanced Pneumatic Compression Devices (APCD) and pneumatic pumps mechanically assist lymphatic drainage by applying sequential pressure, which helps move lymph fluid out of the affected area and reduces fibrosis. Manual lymphatic drainage involves gentle massage techniques to stimulate lymph flow. Compression garments and bandaging provide consistent pressure to prevent fluid accumulation. These treatments are crucial for lymphedema patients as they help manage symptoms, reduce discomfort, and prevent complications such as infections and further tissue damage.

Severe lymphoedema in gynaecological cancers: Impact of pneumatic compression on quality of life.Lymphatic injury alters the contractility and mechanosensitivity of collecting lymphatics to intermittent pneumatic compression.[What physiotherapeutic method for the treatment of post-mastectomy lymphedema is the most effective?]