A non-randomized, open-label study of the safety and effectiveness of a novel non-pneumatic compression device (NPCD) for lower limb lymphedema

Abstract

Lower extremity lymphedema (LEL) can result in detriments to quality of life (QOL) and impose a significant economic burden on patients and payers. A common component of treatment is pneumatic compression, which requires patients to remain immobile. We investigated a novel non-pneumatic compression device (NPCD) that allows patients to remain active during compression treatment, to see if it reduces swelling and improves QOL. We conducted a non-randomized, open-label, 12-week pilot study of adult patients with primary or secondary unilateral LEL, and measured changes in limb edema and QOL using the Lymphedema Quality of Life Questionnaire (LYMQOL). Twenty-four subjects were enrolled; the majority were female (17) with secondary lymphedema (21). Eighteen completed the study. Statistically significant improvements were observed in overall QOL, aggregated LYMQOL total score, and three of four LYMQOL subscales (Function, Appearance, Mood). The fourth (Symptoms) trended toward significant improvement (p = 0.06). The average reduction in affected limb edema was 39.4%. The novel NPCD produced statistically significant improvements in QOL, functioning, and edema volume of patients with LEL. Innovations in devices to manage LEL can be effective while allowing patients to maintain mobility and physical activity during treatment.

Various Therapies for Lymphedema and Chronic Venous Insufficiency, Including a Multimodal At-Home Nonpneumatic Compression Treatment

“…21,22 However, APCDs are bulky, nonportable medical equipment that are cumbersome to use, with reported poor adherence. 23 More recently, clinical studies [25][26][27] involving an NPCD have reported an approach that encompasses multiple established treatment modalities and shows early promise of improved clinical efficacy, quality of life, and patient adherence.…”

“…Results from these studies, including a multicentered randomized crossover trial, indicate that the NPCD provided better edema reduction per patient self-reporting, greater edema volume reduction, and increased quality of life and patient satisfaction compared with APCD. [25][26][27]…”

“…More recently, clinical studies 25–27 involving an NPCD have reported an approach that encompasses multiple established treatment modalities and shows early promise of improved clinical efficacy, quality of life, and patient adherence.…”

“…Three clinical studies 25–27 have demonstrated the clinical benefits of NPCD, noting that its light form factor encourages patient use and improved adherence. Results from these studies, including a multicentered randomized crossover trial, indicate that the NPCD provided better edema reduction per patient self-reporting, greater edema volume reduction, and increased quality of life and patient satisfaction compared with APCD 25–27 …”