Over the course of 2013/2014, we will be engaging in a series of studies and clinical trials to better elucidate the potential of the SurroSense Rx™ and SurroGait Rx™ devices in preventing diabetic foot complications and improving the lives of people affected by the disease. Included in these studies will be smaller, proof-of-principle studies, as well as larger scale clinical trials.
SurroSense Rx™ System
Calibration / Proof of Principle Study
Orpyx® has teamed up with Dr. Reed Ferber and the rest of the fantastic team at the Running Injury Clinic at the University of Calgary to complete calibration and proof of principle studies. Ten healthy participants are being tested with the SurroSense Rx™ device to ensure sensor validity (against gold standard pedobarographs) and efficacy and usability of the auditory and visual feedback system that is built into the device. This series of studies is funded by the Mitacs IRAP Accelerate Program.
Dr. David Armstrong, Director of SALSA (the Southern Arizona Limb Salvage Alliance) is acting Principal Investigator for a pilot study designed to investigate the clinical efficacy of the SurroSense Rx™ device. Thirty diabetic neuropathic patients with the device will be followed for three months. Outcomes of interest include: incidence of ulceration, amputation, infection, surgical intervention, hospitalization, mortality, as well as balance and gait outcomes.
Randomized Controlled Trial
The team at SALSA are also in the process of designing a large-scale, multi-center, randomized, placebo-controlled trial with the SurroSense Rx™ device. Outcomes of interest here include the above clinical, as well as pharmacoeconomic, outcomes. Publishable research data will be available in 2014.
SurroGait Rx™ System
Proof of principle and clinical studies are in the works for the SurroGait Rx™ device. We will post more information as it becomes available.
For all these studies, as results become available, we will be posting them to this section of the website. These results will also be published in our monthly newsletter, so we strongly encourage you to sign up here.