Clinical Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity

Launched by CARILION CLINIC · May 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device designed to help treat lymphedema, which is a painful condition caused by fluid buildup in the arm. The goal of the research is to see if this device is safe and effective for people with lymphedema in their upper arms. If you are 18 years or older, have been diagnosed with lymphedema, and are currently receiving weekly treatment from a physical or occupational therapist, you might be eligible to participate in this study.

As a participant, you will wear the device for about 40 minutes during your regular treatment. Before and after using the device, the researchers will measure your arm size and ask about your pain level and any side effects you may experience. After using the device, you will continue to receive standard treatment for your lymphedema. The study aims to understand how the device affects arm size and any side effects that may occur. Your participation could help improve treatment options for people with lymphedema in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older
• • Clinical diagnosis of lymphedema
• • Receiving current, once weekly, lymphedema treatment by Physical Therapist(PT)/Occupational Therapist (OT)
• • Participants must have the ability to provide consent for themselves
• Exclusion Criteria:
• • Active infection
• • Active cancer (not in remission)
• • Diagnosis of/past medical history of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
• • Active phlebitis
• • Diagnosis of Congestive Heart Failure (CHF)
• • Previous severe trauma (i.e. requiring extensive corrective surgery)
• • History of vascular surgery
• • Lesions of the skin or weeping in the treatment area