Novel approach to improved wound management : Research : Biotechnology : Science + Technology : National Physical Laboratory

Novel approach to improved wound management

Studies indicate that the current cost of chronic wound management is about 3% of the annual NHS budget circa £3bn (DH 2010 & Posnett 2007). Roughly 80% of this figure is attributed to delayed healing and wound complications (Drew 2007), thus the ability to quickly and accurately identify wound type and the underlying wound aetiology is of the utmost importance. New technologies to improve clinical wound management by identifying specific biological imbalances or complications such as early stage infection, however, are few and far between and there is currently a tendency to assess and treat wounds on the basis of subjective data, e.g. colour, smell, etc.

In an effort to provide a more objective means to wound management, the Biotechnology Group has recently completed a successful Technology Strategy Board funded project (entitled 'RegeniTherix^TM - smart scaffolds for optimised wound healing') to develop a novel theranostic wound management system based on Neotherix's 3D bioresorbable scaffold and a thermally reversible hydrogel they developed within the project. The purpose of the scaffold is to assist wound repair, and the hydrogel to facilitate capture and sampling of biomarkers and indicators of wound status from the scaffold when it is applied to the wound bed. Removal of a sample of hydrogel from the scaffold and cooling causes the hydrogel to revert back to a liquid state and release entrapped biomarkers so they can be measured. Within the project, NPL's role was to develop and validate a third component: a simple, inexpensive companion point-of-care (POC) assay to enable the measurement of the wound biomarkers at the bedside. Currently, biochemical measurements are rarely performed in hospitals due to the difficulty of sampling wounds and the need to send samples away for centralised testing. Using Interleukin 6 and Tumor Necrosis Factor alpha as model wound analytes, members of the NPL team were able to accurately measure analytes within hydrogel-based samples at concentrations meeting clinical requirements. To do this they relied on the same assay principle as used in home pregnancy tests (i.e. a lateral flow immunoassay) and extended the principle to demonstrate for the first time ever quantitative within test-line spectral multiplexing of biomarkers.

Together the components of the RegeniTherix^TM system may assist wound repair, allow more efficient and convenient sampling, enable identification of wound imbalances and infection and guide selection of complementary treatments such as advanced wound management products and topical antiseptics. The consortium's ultimate goal is to develop a product that reduces NHS costs (through improved identification of wounds that will best respond to certain treatments) at the same time as improving patient care and quality of life. Along with pain and discomfort, patients with chronic wounds (venous and arterial ulcers, diabetic foot ulcers, pressure ulcers) may experience loss of sleep, reduced mobility and social isolation.

The consortium has obtained follow-on funding from the National Institute of Health NIHR's 'Invention for Innovation' programme to test the technology in a clinical setting en route to obtaining CE marking. NPL's work has recently been published.

Interested parties can also email Graham Worsely for more information.

Our partners have stated the following

Neotherix Ltd:
Neotherix develop regenerative scaffolds for tissue repair, and the successful progression of the RegeniTherix theranostic technology to improve the management of problem, non-healing wounds is an important component of our product development pipeline.

"NPL's measurement expertise has been instrumental in the development of the point-of-care immunoassay, allowing the team to establish proof-of-concept for RegeniTherix. We look forward to continuing our fruitful partnership with NPL and the other members of the project consortium in order to commercialise this novel technology."

References

Worsley GJ, Attree SL, Noble JE, Horgan AM. Rapid duplex immunoassay for wound biomarkers at the point-of-care. Biosens. Bioelectron. 2012, 34, 215-220
Department of Health (2010) Equity and Excellence. Liberating the NHS. ISBN 9780101788120
Drew P, Posnett J, Rusling L. The cost of wound care for a local population in England. Int J Wound 2007; 4: 149-55
Posnett J, Frank PJ. The costs of skin breakdown and ulceration in the UK. In: Pownall M, ed. Skin Breakdown: The Silent Epidemic. Smith and Nephew Foundation, Hull; 2007: pp 6-12

Acknowledgements

The RegeniTherix consortium would like to thank the Technology Strategy Board for funding the proof-of-concept work. The National Physical Laboratory would also like to thank the National Measurement Office (NMO).