Title: An innovative system for the early identification, monitoring, evaluation and diagnosis of diabetic foot ulcers
Funder: Department of Health (England)

Abstract: Ethical, site specific, approvals will be sought by each clinical partner on approval of the project. WP1 (NPL/ Photometrix/UoSW/King's/Freeman/Pennine ): Specification requirements for DFUPS Establishment of PPI panel/advisory group Small cohort assessment (n= Survey end users (medical physicists/GPs/podiatrists) and public/patients Focused follow up interviews WP2 (Photometrix/ UoSW/NPL ): Manufacture of first prototype DFUPS, testing and validation Design and manufacture of prototype devices (x5) – informed by study in WP1 Design and manufacture of temperature reference artefact traceable to national standards Image analysis algorithms constructed Laboratory testing and validation of prototype DFUPS with temperature reference WP3 (King's/ Freeman/Pennine/Photometrix/UoSW/NPL ): First clinical field trials of prototype DFUPS (A) Normal (non presenting) group (n=100) (B) Iteration of design and re-engineering of DFUPS (A) Stage 1 Clinical Assessment Field Trials: Training in use of DFUPS 100 non presenting volunteers: comparison of temperature maps from prototype DFUPS against results from current gold standard assessment Setting: diabetic foot clinics Approach: randomised controlled study Primary outcome: superiority (in terms of speed, patient acceptability and clinical assessment) compared to gold standard Secondary outcomes: a definition of normal ranges and normal variability of foot temperature Design assessment feedback, reporting (B) Iteration of design and re-engineering of DFUPS in light of findings Modification of hardware/software Manufacture of the second clinical prototype DFUPS Laboratory functionality testing and validation of second prototype DFUPS versus temperature reference WP4 ( King's/ Freeman/Pennine/Photometrix/UoSW/NPL ): Second clinical field trials of second DFUPS High risk DFU group (n=100) Stage 2 Clinical Assessment Field Trials: Training in use of DFUPS Clinical assessment of second prototype DFUPS on high risk patients (n=100) Setting: diabetic foot clinics Approach: randomised controlled study Population: n=100 people with diabetes complicated by peripheral neuropathy and history of 1 or more resolved DFUs over the preceding year. All patients should have palpable foot pulses, indicating that the large vessel blood supply to the feet is not compromised. Summary: Subjects will be randomised either to DFUPS and standard care or standard care alone. Each subject will be reviewed at 4 week intervals for 1 year with or without thermometry of both feet at each visit. In the event of an identified temperature rise appropriate multidisciplinary care will act to prevent ulceration in line with local and national guidance Primary outcome: improved prevention of recurrent foot ulceration demonstrated Secondary outcomes: reduced time to healing, ulcer size and duration, requirement for hospitalisation. Improved quality of life (as measured by EQ-5D tool), usability feedback from podiatrists and patients Critical result assessment feedback/reporting WP5 (Photometrix/ UoSW/NPL ): Development of pre-production DFUPS Modifications to design to pre-production DFUPS device Consultation with user groups to ensure fit-for-purpose/ergonomic design Real time-image analysis algorithms and alerts (e.g. red/amber/green) with potential problem areas of foot automatically identified on foot image Laboratory testing and validation versus temperature reference WP6 (NPL/ All ): Knowledge transfer Project website Technical papers Presentations at appropriate conferences/meetings Briefing documents/articles in professional press to ensure widespread dissemination Demonstration of device at appropriate medical trade shows and diabetes events WP7 (NPL/ All ): Management NPL is ISO9001 accredited for its management processes and these will be followed for this project. Progress review meetings will be held quarterly. On completion of the WPs the results will be reviewed by the full project team, PPI panel and invited experts and Advisory Group. Benefits and technical risks will be identified. Commercial opportunities will be identified and exploitation plans proposed, and new IP identified.


Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: METABOLIC AND ENDOCRINE;SKIN