Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Apr;20(2):125-132.
doi: 10.1089/lrb.2020.0126. Epub 2021 Jul 2.

Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study

Stanley G Rockson  1 , Pinar Karaca-Mandic  2 , Roman Skoracki  3 , Karen Hock  3 , Michelle Nguyen  4 , Kristin Shadduck  4 , Phyllis Gingerich  5 , Elizabeth Campione  6 , Andrea Leifer  7 , Jane Armer  8
Affiliations

Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study

Stanley G Rockson et al. Lymphat Res Biol. 2022 Apr.

Abstract

A diagnosis of lymphedema comes with a lifetime requirement for careful self-care and treatment to control skin deterioration and the consequences of excessive fluid and protein buildup leading to abnormal limb volume and an increased risk of infection. The burden of care and psychosocial aspects of physical disfiguration and loss of function are associated with compromised quality of life (QoL). The current standard therapeutic intervention is complex decongestive therapy with manual lymph drainage and frequent wearing of compression garments. With insurance limitations on therapy visits and the time and travel required, additional home treatment options are needed. Pneumatic compression pumps that mimic the manual massage pressure and pattern are sometimes prescribed, but these are bulky, difficult to apply, and require immobility during treatment. An open-label pilot study in 40 subjects was performed to evaluate the QoL and limb volume maintenance efficacy of a novel wearable compression system (Dayspring™) that is low profile, easy to use, and allows for mobility during treatment. After 28 days of use, subjects had a statistically significant 18% (p < 0.001) improvement in overall QoL as measured by the Lymphedema Quality-of-Life Questionnaire compared with baseline. Individual QoL domains, and limb volume improved with therapy. Adherence was 98% over the course of the study. Results of the clinical evaluation suggest the Dayspring wearable compression device is safe and effective and improves QoL and limb volume. The novel, low-profile device is easy to use and allows for mobility during treatment, addressing a potential barrier to adherence with pneumatic compression devices.

Keywords: advanced compression; lymphedema; mobility; quality of life; wearable.

PubMed Disclaimer

Conflict of interest statement

Dr. S.G.R., Dr. P.K.-M., Dr. R.S., and Dr. J.A. serve as advisors to Koya Medical. Over the past 24 months, Dr. P.K.-M. reports providing consulting services to Precision Health Economics and Sempre Health for work unrelated to this study. The authors have no financial interests in the study.

Figures

FIG. 1.
FIG. 1.
Schematic of the Dayspring—a smart wearable device—shown with the controller (right) and garment (left).
FIG. 2.
FIG. 2.
Lymphedema overall quality-of-life (LYMQOL) outcomes from subjects before and after use of the Dayspring device over a 1-month evaluation period. Horizontal bars represent mean ± 1 standard deviation. LYMQOL, Lymphedema Quality-of-Life Questionnaire; QoL, quality of life.
FIG. 3.
FIG. 3.
Lymphedema qualify-of-life (LYMQOL) functional outcomes from subjects before and after use of the Dayspring device over a 1-month evaluation period. Horizontal bars represent mean ± 1 standard deviation.
FIG. 4.
FIG. 4.
Volume reduction in subjects before and after use of the Dayspring device over a 1-month evaluation period. Horizontal bars represent mean ± 1 standard deviation.
FIG. 5.
FIG. 5.
Dayspring companion app for digital interface and adherence monitoring.
FIG. 6.
FIG. 6.
VAS score in preference of Dayspring over PCDs from subjects after the trial. PCDs, pneumatic compression devices; VAS, visual analog scale.
See this image and copyright information in PMC

References

    1. Underlying incidence data are from the SEER 9 areas. http://seer.cancer.gov/registries/terms.html (accessed June 29, 2021).
    1. Carvalho AL, Nishimoto IN, Califano JA, Kowalski LP. Trends in incidence and prognosis for head and neck cancer in the United States: A site-specific analysis of the SEER database. Int J Cancer 2005; 114:806–816. - PubMed
    1. Noone A-M, Cronin KA, Altekruse SF, Howlader N, Lewis DR, Petkov VI, Penberthy L. Cancer incidence and survival trends by subtype using data from the surveillance epidemiology and end results program, 1992–2013. Cancer Epidemiol Prev Biomark 2017; 26:632–641. - PMC - PubMed
    1. Beckjord EB, Reynolds KA, Van Londen G, Burns R, Singh R, Arvey SR, Nutt SA, Rechis R. Population-level trends in posttreatment cancer survivors' concerns and associated receipt of care: Results from the 2006 and 2010 LIVESTRONG surveys. J Psychosoc Oncol 2014; 32:125–151. - PMC - PubMed
    1. Hayes SC. Review of Research Evidence on Secondary Lymphoedema—Incidence, Prevention, Risk Factors and Treatment. NSW: National Breast and Ovarian Cancer Centre Surry Hills; 2008:1–83.

Publication types