SANUWAVE Launches Two Studies: Perfusion and Dosing; Results Expected in 2019

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[{"type":"text","content":"Suwanee, GA, April 04, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCBB:SNWV) (www.sanuwave.com): SANUWAVE® is pleased to announce initial enrollment beginning this week in two company-sponsored studies. First, SANUWAVE is sponsoring an initial case series to quantify the level of increased perfusion and oxygenation during and after treatment of Diabetic Foot Ulcers (DFU's) with the dermaPACE® System. This study will be conducted at two sites, with the primary site located at the Vascular and Wound Care Center at University Hospital, Rutgers NJMS, Newark, NJ with Dr. Mark Grannick as the Principal Investigator and Dr. Oscar Alvarez as the Co-Principal Investigator. The second site is located at the Olive View-UCLA Medical Center with Dr. Aksone Nouvong leading the effort and enrollment beginning by the end of April.Previous animal studies and clinical work using the dermaPACE® System have shown that treated tissue exhibits increased perfusion to the area as measured by Doppler imaging and also increased venule and arteriole diameters, indicating increased red blood cell velocity. This case series will utilize spectral imaging to measure oxygen saturation, oxyhemoglobin level, and deoxyhemoglobin level in superficial tissue and using TcPO2 values as a control. This initial case series will help us to quantify these increases and will help us to better understand how dermaPACE® works, leading to future research and improvement of clinical protocols for the treatment of Diabetic Foot Ulcers and other skin conditions.A second, more extensive study will assess the response of DFU's treated with an increasing number of shockwaves/pulses. In our U.S. based Phase III trial measuring the effects that treatment of DFUs in conjunction with Standard of Care as compared to Standard of Care alone, a single dosage regimen of 500 shocks/treatment was used. In this new three-arm study, to be conducted at NZOZ PROFIL Private Wound Clinic from Poznan, Poland, the researchers will observe how DFU's respond to the dermaPACE® System treatment in conjunction with Standard of Care in three different dosage regimens that use a higher number of shockwaves when compared to the U.S. Phase III study. The Principal Investigator for this study is Professor Tomasz Banasiewicz, who is the head of Department and Clinic of General, Endocr...

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