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A Cost-Effective Photonics-based Device for Early Prediction, Monitoring and Management of Diabetic Foot Ulcers

Periodic Reporting for period 1 - PHOOTONICS (A Cost-Effective Photonics-based Device for Early Prediction, Monitoring and Management of Diabetic Foot Ulcers)

Reporting period: 2019-11-01 to 2020-10-31

Diabetic Foot Ulcer (DFU) is one of the most common complications of diabetes, caused by neuropathic (nerve) and vascular (blood vessel) problems: annually, up to 4% of those with diabetes develop a foot ulcer and 10-15% of those with diabetes will have at least one-foot ulcer during their lifetime. Moreover, chronic DFUs are the most common indications for hospitalization for diabetic patients, and the direct cause for 50% of all non-traumatic amputations. The cost of care for patients with a foot ulcer is 5.4 times higher after the first ulcer episode, as they require more frequent emergency department visits and longer stays. In this regard, the global market for diabetes diagnostics devices and systems generated a revenue of $9,040 million in 2014 and it is forecast to reach $14 billion by 2022.
The main objective is to develop innovative, reliable and cost-effective (in terms of almost zero operational cost and high return of investment) photonic-driven devices for Diabetic Foot Ulcers (DFU) monitoring and management which can be applied for wide use.
The key strategic objectives are:
1. To develop reliable devices for DFU monitoring: The proposed devices combine passive IR photodetectors with active illuminators. Specifically, we deliver (i) a passive HSI photo-detector, sensitive at NIR spectrum of 700nm-1000nm with an active tuneable diode illuminator, operating at NIR spectrum, for optimising reliability (in terms of sensitivity, specificity and accuracy) in detecting peripheral oxygen and tissue saturation- SpO2/StO2 and oxyhaemoglobin/deoxyhaemoglobin, at a spatial resolution of approximately 50pixels/cm, (ii) a passive Mid-IR photodetector, sensitive at spectrum 5.7μm-9.3μm with a Quantum Cascade Laser optimized to capture additional tissue attributes such as elastin, collagen, lipid, amino amino-acids and carbohydrates necessary information for DFU early prediction and management and (iii) a thermal-IR sensing component capable of detecting hyperthermia/hypothermia distributions in ROIs with different levels of resolution for the PRO and In-Home version.
2. To develop cost-effective devices for DFU: We (i) employ photonic enabled technologies targeted specifically for capturing key medical indicators for ulcer healing and monitoring, (ii) implement state of the art signal processing and machine learning algorithms to increase the discrimination accuracy while maintaining hardware cost-benefit, (iii) develop a user-friendly interface in order to allow these devices to be operated by non-certified physicians, and even by patients (for the simplified In-Home version), and (iv) minimise operational cost in the monitoring and management of DFU
During the first 12 months the consortium performed significant progress and executed the bulk of the envisaged tasks. Regarding the dissemination and communication activities, the Project Website was launched and the 1st version of the Project Communication Kit was prepared. The detailed analysis on existing medical equipment, as well as the medical meta-analysis of DFU diagnosis, monitoring and management were prepared. Based on these details, we gathered the outcomes of existing values in terms of (a) medical indices use, (b) the value ranges of these indices, (c) how gender and age can affect the value ranges, (d) excluding criteria and (e) percentage of correlation of the medical indices with the disease and its progress. Taking into account the outcomes of T3.1 and T3.2 and interaction with the medical community, the user requirements and technical specifications of the system have been concluded in Task 3.3. This includes (a)the type of sensors, (b)the value ranges, (c) their spatial resolution, (d) the response time and (e) portability issues. A diverse range of photonic imaging techniques have been selected based on the described clinical indexes for DFU management. Technical specifications cover both versions; the HOME and the PRO version. Also, we defined the exploitation and use plans and started to investigate the wide deployment of the PHOOTONICS technology. To that end, the first interim exploitation reporting was the first step to building the value proposition and preparing a concise business plan following validated results, as well as investigating any patenting potentials. The first interim report on IPR & standardization allowed us to review the project developments from the POV of Standards, Legal and Regulatory issues that are related to technical aspects at National, European and – up to a point - International level. Meanwhile, the consortium partners have already commenced work as expected by the work plan for the main technical components development Work Packages 4,5 & 6.
Progress beyond the state of the art

Hyperspectral NIR Sensing for Diabetic Foot
The goal is to activate the tuneable diodes when a vague result is obtained by the HSI sensor to disambiguate the vagueness and increase accuracy and sensitivity in detecting pathology in a diabetic foot.
Tuneable Diode Lasers (TDLs)
PHOOTONICS aims to introduce such in-silicon sensor, utilizing all possible advantages of the various subcomponents to support the treatment of diabetic foot disorders. The goal of this innovation is to improve the accuracy in detecting haemoglobin and the StO2 and SpO2 values especially in regions where we have a great disambiguation.
Thermal Sensors
In PHOOTONICS project, we optimize an IR sensor to yield a discrimination analysis of less than 100mK differences and of spatial resolution of 10 pixels/com for the In-Home version and full HD for the PRO version. In PHOOTONICS thermal imaging is combined with QCLs to disambiguate the performance of a DFU monitoring in case that some evidences occur.
Quantum Cascade Lasers (QCLs)
In QCLs, PHOOTONICS will extend the current state of the art in the following directions:
1. It provides an in-Silicon solution that captures specific spectral bands, focusing on diabetic foot disorder detection. This results in a cost-effective (low operational cost and of high return of investment) device that increase the application scenarios of the delivered sensor.
2. It combines data with other PHOOTONICS sensors to result in a high SNR of capturing the particular bio-markers for diabetic foot.
3. It delivers spectral information at high rates supporting real-time application scenarios as the ones PHOOTONICS project supports.
Embedded Adaptive Signal Processing and Machine Learning
The goal is to improve the reliability in the analysis by non-linearly processing the data and thus getting some knowledge on diabetic foot disease progress.
Clinical Study Validation
PHOOTONICS will promote a massive use of DFU monitoring and management to improve quality of life for the patients.

Contribution to Innovation Capacity and Integration of New Knowledge
PHOOTONICS aims to optimize and explore the feasibility of an improved technology. Knowledge is brought into the consortium by all partners and is further developed to deliver and validate the complete approach.
• The main innovation is in the development of a cost-effective and of advanced reliability photonics IR device for regular monitoring of DFUs.
• The sensing elements of PHOOTONICS are integrated in a portable and of ease of use instrument.
• The participating companies will be given the opportunity to market a modular and configurable product