Clinical Research

(CR-009) Evaluation of the efficacy and safety of a two layer Dual Compression System (DCS)* bandage system in the treatment of lower limb lymphedema

Co-Author(s):

Introduction: Primary lymphedema is a chronic illness due to a lymphatic system dysfunction. Lymph fluids collects abnormally typically in lower limb subcutaneous tissues. There is no permanent cure. A combination of cutaneous care, lymphatic drainage, exercises in association with compression bandaging allows an appropriate management of this pathology. Lymphedema is found in 0.13-2% of population, and negatively impacts quality of life. A novel two-layer Dual Compression System, which combines both long and short stretch elements, and is engineered to provide therapeutic compression (20/40mm), is well known in treatment of venous insufficiency. Recently, DCS indications have been extended to lymphedema management. Methods: A clinical evaluation was conducted in an outpatient hospital setting, recognized for its expertise in lymphedema, to evaluate efficacy of this two-layer Dual Compression System Bandage in this pathology ; The primary outcome criterion was the volume reduction of the lower limb after treatment and an assessment of the safety of the system in lymphedematous conditions in the lower limb. Results: 8 patients with lower limbs primary lymphedema advanced Stage II, mean age 64 years, mean BMI over 41kg/m² were included in this clinical evaluation. After 33 days of mean treatment duration, a 8% volume reduction (mean value) was documented, combined with a good local tolerance. The acceptability of the tested compression system was considered by the patient as “good” and “very good” for day/night comfort. Discussion: The DCS compression bandage system is judged as effective and well-tolerated in this chronic pathology and may play an important role in the treatment of lower limbs lymphedema. Further studies are needed in this area. It is possible that the respective dynamics of the short stretch and long stretch bandages come together in synergistic ways to provide lymphedema relief. Biomechanical studies are warranted in this area. Trademarked Items: UrgoK2 Compression Bandage References: 1. Ayman A. Grada, Tania J. Phillips, Lymphedema: Pathophysiology and clinical manifestations, Journal of the American Academy of Dermatology, Volume 77, Issue 6, 2017, Pages 1009-1020,
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