Study of a Novel Portable Non-Pneumatic Active Compression Device for Treating Lymphedema and Phlebolymphedema Evaluating Effectiveness and Health Costs in Adults

What this Trial Is About

This research aims to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device NPCD called Dayspring for people with lymphedema or phlebolymphedema, conditions related to chronic venous insufficiency affecting the lower limbs. The study is open-label and conducted at multiple centers, focusing on how this device may impact health outcomes and costs. Participants will use the Dayspring device, an FDA-cleared active wearable compression garment that applies controlled, sequential pressure from the lower to upper parts of the limb in cycles. This device is programmable and designed to help manage symptoms by improving blood and lymph flow. The study lasts for six months and includes monitoring the devices performance and effects on the participants. Throughout the study, participants will be assessed for changes in limb swelling, mobility measured by daily steps, venous clinical severity, and hospital resource use related to adverse events. Safety and any side effects will also be tracked. The total study duration for each participant is six months, with regular evaluations to monitor progress and health status.

Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema