Longitudinal Assessment of Health-Related Quality of Life and Clinical Outcomes with At-Home Advanced Pneumatic Compression Treatment of Lower Extremity Lymphedema

Participants were recruited at four VA medical centers from 2016 to 2022. The study enrolled 251 participants, with 179 completing the 52-week study. This is the largest enrollment of any U.S. prospective clinical trial published in the United States investigating pneumatic compression devices and lymphedema.

Participants were instructed to use the Flexitouch® or Flexitouch Plus APCDs daily, along with other conservative treatments as prescribed by their physician.

Key Results:

• Flexitouch® compliance was 92% at 8 weeks and 72% at 52 weeks.
• 6% limb girth reduction at 12 weeks in patients with moderate (stage 2) and severe (stage 3) lymphedema when compared to baseline.
• Cellulitis episodes reduced by 71%.
• Lymphedema Quality of Life (QoL) score increased from 6.2 to 6.9, on a scale from 0–10, which includes improvements in function, appearance, symptoms, and emotion.
• There was a 15% increase in elastic compression compliance (from 64% at baseline to 74% at 52 weeks).

The study concluded that adjunctive use of at-home Flexitouch APCD treatment resulted in significant improvements in health-related and general quality of life measures.