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.