Aim: The aim of the study was to assess efficacy and safety of a new medical device, based on electric microcurrents and vacuum mechanism, on lymphedema of the lower limbs.
Methods: This was an observational clinical and instrumental study was performed on eight patients (2 males and 6 females, mean age 40.5 years), affected by secondary (3) or primary (5) lymphedema of the lower limbs. Ten daily sessions with an electro-sound wave and vacuum medical device were performed. Patients did not discontinue antecedently worn compression stockings. Lymphoscintigraphy of the lower limbs was performed before and after the treatment and an independent observer scored the images. Circumference tape measurement and relative volumetry were calculated before and after the treatment.
Result: Total limb mean volumetry decreased from 9145 cc (±3439 SD) to 8714 (±3307) after 10 sessions (5% improvement); reduction in the lower leg volumetry was 8%. Ankle and mid calf mean circumference (in cm) decreased from 27.7 to 27.2 and from 36.2 to 35.2. Popliteal and inguinal lymph node visualisation at lymphoscintigraphy improved of 72%, 41%, 95% and 192% and of 0%, 33%, 110% and 245% respectively, 5', 45',120' and 180' after the injection. Radiotracer ascension along the leg and the thigh increased respectively of 48% and 33%, 39% and 64%, 50% and 62% and finally of 55% and 78% at the same intervals. Dermal back flow did not significantly vary till 45', whereas it improved of 25% both 120' and 180' after injection. No side effects were highlighted during the treatment.
Conclusion: In this observational study the application of a medical device, based on bioresonance and vacuum mechanisms, on limbs with lymphedema proved to be both safe and effective in terms of limb volume reduction and of lymphoscintigraphy parameters.