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RCSI extends partnership with BBI LLC on diabetic foot ulcer prevention research

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The Skin Wounds, and Trauma (SWaT) Research Centre at RCSI has partnered with BBI LLC (Bruin Biometrics), a developer of innovative sensor-based diagnostic products, to undertake a number of collaborative projects that will employ BBI’s sub-epidermal moisture (SEM) Scanner.

The planned study includes the use of BBI’s SEM Scanner to identify diabetic foot ulceration (DFU) before it is visible. This research will help clinicians make better evidence-based decisions, and ultimately improve the quality of life for those at risk of developing DFUs while saving services money.

“The team at the Skin Wounds, and Trauma (SWaT) Research Centre at RCSI is delighted with the opportunity to extend our partnership with BBI LLC. Our research collaboration to date has yielded highly significant clinical data, mainly in the area of pressure ulcer prevention. The planned study will extend our research relationship into the area of diabetic foot ulceration and how it can be prevented through earlier identification by the analysis of the role of biocapacitance technology in DFU prevention,” said Professor Zena Moore, Director, SWaT Research Centre, RCSI.

“At the heart of our research are patient outcomes that will improve patient quality of life. Our aim is that this study will continue to make a significant mark on the area of earlier identification of diabetic foot ulceration with the resultant outcome that the lives of patients and their families are improved,” concluded Professor Moore.

The research programme will continue to explore biocapacitance science as a novel methodology supporting DFU prevention. It seeks to radically alter the progression of the disease while contributing to the biological understanding of DFU development, the underlying pathophysiology and biomarkers, such as SEM. The ultimate aim is to prevent DFU and reduce the prevalence of this significant public health problem.

“I am delighted to extend the partnership with the RCSI, and I look forward to the new advances our continued collaboration will bring in the prevention of this pernicious clinical problem,” said Martin Burns, CEO, BBI LLC.

“This research takes advantage of RCSI’s unique ability to foster meaningful collaborations between researchers, clinicians and industry partners. I welcome this continued partnership, and I look forward to the improvements that this could bring for the benefit of patients’ health.

Diabetes is a growing epidemic, with associated complexity of treatment and management from a wound care perspective, prevalence of foot ulceration reaches as high as 10%. Diabetes is the leading cause of non-traumatic limb amputation in the world. Within 18 months following amputation, almost 50% of individuals will develop an ulceration on the other limb, and 58% of these individuals will have further amputations within three to five years.

The three-year mortality rate after the first amputation is between 20-50%. This is down to the motor and sensory neuropathy associated with diabetes, resulting in damage to the foots nerve supply. This chain of events leads to further bone, joint and soft tissue damage, which can lead to irreversible cell destruction.

Quality of life is threatened through mobility loss, subsequent social functioning and intractable pain experienced in almost 50% of these patients. Within healthcare, DFU represents estimated costs of €4-6 billion in light of a 1-1.4 million prevalence, placing a significant burden on resource.

The SEM Scanner received European CE Mark approval in 2014 and Health Canada clearance in 2016 and is in full commercial use in Australia, New Zealand, Canada and the European Union including the UK, Belgium and Spain with additional markets expected to be opened in 2019. Additionally, FDA Authorisation to market the SEM Scanner in the USA was received in December 2018.