The main objective set forth by PHOOTONICS 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 infrared 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 (QCL) optimized to capture additional tissue attributes such as elastin, collagen, lipid, amino amino-acids and carbohydrates necessary information for DFU early prediction and management at a resolution scale approximately of 10pixels/cm. 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 (full HD and 10 pixels/cm respectively).
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 (between healthy and non-healthy tissues) 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 by replacing invasive and costly practices with our non-invasive device and zero-consumables devices.
Diabetes is a major public health issue for Europe, with diabetes affecting about 9,1% of the population in Europe. This represents a major economic burden to the healthcare system with annual cost reaching €7- 10 € billion to direct yearly costs, across EU. Therefore, healthcare providers and payers need an urgent solution to help eliminate avoidable diabetes-related complications. To combat this significant challenge, METISBALTIC, the coordinator of PHOOTONICS, have developed FEETWELL – a data-driven, user friendly, and patient-oriented medical device concept, that will diagnose DFUs and prevent frequent, costly and avoidable complications of DFUs. According to the World Health Organization, the global prevalence of diabetes among adults over 18 years of age has risen from 4.7% in 1980 to 8.5% in 2014, when 422 million adults in the world suffered this disease, and forecasts do not indicate a declining trend. 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 project supports two versions: (i) the PHOOTONICS In-Home, used for DFU monitoring by patients and (ii) the PHOOTONICS PRO operated by physicians at their premises.
PHOOTONICS In-Home: The In-Home version is designed to be dedicated for patients. It includes the optimized low-cost IR sensor with the embedded signal/processing tools in order to increase the resolution performance, reduce noise and provides high-level decision-making mechanisms.
PHOOTONICS PRO: The PRO version is dedicated for physicians at their offices or at hospitals. It enhances the In-Home version by including the i) optimized HSI sensor, combining with the IR hyperthermia photodetector, ii) the optimized Mid-IR Sensor and iii) the activities HSI illuminator to increase reliability and provide measurements of additional attributes (e.g. tissue properties), while simultaneously keeping the cost affordable for professional use.
The PHOOTONICS project comprises five phases: i) The Preparation phase, ii) the Photonic-enabled fabrication phase, iii) the Clinical Studies phase, iv) the Integration phase, and v) the Feedback phase.
Preparation phase: The project commences with the preparation phase where the scene is set. The main activity of this phase is a meta-analysis of existing clinical trials, applying photonic-enabled technologies in DFUs prediction and healing. A meta-analysis is a statistical analysis that combines the results of multiple clinical trials in order to conclude to a common user-requirement framework. The output of this phase is a set of medical indicators and should be captured by the PHOOTONICS device in order to provide an early management and prediction of DFUs. Based on these medical indicators a set of technical specifications are provided in a way to guide the next photonic enabled fabrication phase.
Photonic-enabled fabrication phase: The objective of this phase is to optimized and deliver the PHOOTONICS device. Hardware and software components are included.
- Hardware components are divided into two main categories; the passive photodetectors (HSI NIR, mid IR and thermal in-silicon sensors) and the active HSI illuminators, exploiting tuneable diodes of NIR and QCL technology of mid-IR. Innovation is focused i) on optimization of existing sensing interfaces in order to increase reliability (sensitivity, specificity and accuracy) in detecting medical indicators (e.g., SpO2, StO2, hyperthermia) and ii) on combining them with active illuminators in order to detect additional tissue properties (e.g., elastin, collagen, water absorption) useful for DFU management.
- Software embedded components includes advanced signal processing and learning tools in order to reduce SNR ratio, increase spatial resolution of the sensors and provides a high-level interpretation of the raw detected information, transforming low level descriptors (e.g., levels of elastin, collagen, water, SpO2, HbO2, Hb) into high level medical indices for DFU management.
Clinical studies phase: In this phase the developed device is evaluated in clinical studies. Validation concerns where the delivered device is capable of capturing the necessary medical information needed for early prediction and management of DFUs. It should be mentioned that the main objective of this project is to deliver a cost-effective photonic enabled device of advanced reliability capabilities in detecting critical medical factors for DFUs. Clinical studies aim at validating the performance of the device in real life clinical settings.
Integration phase: Integration activities starts after the delivery of the PHOOTONICS software components. It comprises two phases. After the first integration phase, results from the first clinical study are taken into consideration as feedback for the second integration phase. The outcome of the second integration phase is used for further clinical study validation towards the end of the project.
Feedback: An iterative implementation framework is adopted to minimize potential integration risks. Therefore, three clinical studies phases are foreseen. Each study validates the delivered photonic sensors at different clinical settings (e.g., gender, age, type of diabetes – type 1/2). The results are exploited by the technical partners of the project is order to re-configure the developed sensing/photonic interfaces to maximize their performance for the DFU scenario.