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® 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 were tested with the SurroSense Rx™ device to ensure sensor validity (against gold standard pedobarographs). This study was funded by the Mitacs IRAP Accelerate Program. Findings of the study were published in the Journal of Diabetes Science & Technology in September 2013. Read the article here.
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.
Multicenter Randomized Controlled Clinical Trial
Dr. Andrew Boulton's team, in conjunction with Dr. David Armstrong and his team at SALSA (the Southern Arizona Limb Salvage Alliance) are in the process of designing a large-scale, multi-center, randomized, placebo-controlled trial with the SurroSense Rx™ device through the University of Manchester and Lancashire Teaching Hospital. Data collection is to commence Fall 2013 with 96 Diabetic Peripheral Neuropathy patients. Outcomes of interest here include the above clinical, as well as pharmacoeconomic, outcomes.
SurroGait Rx™ System
We have teamed up with renowned biomechanics researcher, Dr. Benno Nigg of the Human Performance Lab (University of Calgary) to complete proof of principle studies on the SurroGait Rx™ device. This study is investigating the impact of the device on gait and balance in patients with peripheral neuropathy.
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 quarterly newsletter, so we strongly encourage you to sign up here.