Periodic Reporting for period 4 - PHOOTONICS (A Cost-Effective Photonics-based Device for Early Prediction, Monitoring and Management of Diabetic Foot Ulcers)
Période du rapport: 2022-11-01 au 2024-06-30
Diabetic Foot Ulcers are one of the most common complications of diabetes, caused by neuropathic and vascular 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. Chronic DFUs are the most common indications for hospitalization, and the direct cause for 50% of all non-traumatic amputations.
The consequences of DFUs are not limited to amputation, and include an increased risk of falls, fractures, reduced mobility, frailty, and mortality. Inevitably, DFUs carry a significant cost to the health system.
PHOOTONICS main aim is the development of innovative, reliable and cost-effective photonic-driven devices for DFU monitoring and management which can be applied for wide use.
The project supports two versions: (i) the PHOOTONICS HOME, used for DFU monitoring by patients and (ii) the PHOOTONICS PRO operated by physicians at their premises.
Key strategic objectives of the project:
1. Developing photonic devices capable of detecting early signs of DFUs through a combination of thermal, hyperspectral, and mid-infrared sensing technologies.
The proposed devices combine passive infrared photodetectors with active illuminators. Specifically, the devices integrate:
• thermal-IR sensing components capable of detecting hyperthermia/hypothermia distributions in ROIs
• passive Mid-IR photodetector, with a Quantum Cascade Laser (QCL) optimized to capture additional tissue attributes at a resolution scale approximately of 10pixels/cm,
• mid-wave infrared Quantum Cascade Laser (QCL) to cover an additional spectral range,
• silicon HSI photodetector optimized at specific NIR spectral bands
• NIR Fluorescence sensor
2. Developing cost-effective devices for DFU monitoring and management. The devices:
• employ photonic enabled technologies targeted specifically for capturing key medical indicators for ulcer monitoring,
• implement state of the art signal processing and machine learning algorithms to increase the discrimination accuracy while maintaining hardware cost-benefit,
• 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 HOME version), and
• minimise operational cost in the monitoring and management of DFU.
The consequences of DFUs are not limited to amputation, and include an increased risk of falls, fractures, reduced mobility, frailty, and mortality. Inevitably, DFUs carry a significant cost to the health system.
PHOOTONICS main aim is the development of innovative, reliable and cost-effective photonic-driven devices for DFU monitoring and management which can be applied for wide use.
The project supports two versions: (i) the PHOOTONICS HOME, used for DFU monitoring by patients and (ii) the PHOOTONICS PRO operated by physicians at their premises.
Key strategic objectives of the project:
1. Developing photonic devices capable of detecting early signs of DFUs through a combination of thermal, hyperspectral, and mid-infrared sensing technologies.
The proposed devices combine passive infrared photodetectors with active illuminators. Specifically, the devices integrate:
• thermal-IR sensing components capable of detecting hyperthermia/hypothermia distributions in ROIs
• passive Mid-IR photodetector, with a Quantum Cascade Laser (QCL) optimized to capture additional tissue attributes at a resolution scale approximately of 10pixels/cm,
• mid-wave infrared Quantum Cascade Laser (QCL) to cover an additional spectral range,
• silicon HSI photodetector optimized at specific NIR spectral bands
• NIR Fluorescence sensor
2. Developing cost-effective devices for DFU monitoring and management. The devices:
• employ photonic enabled technologies targeted specifically for capturing key medical indicators for ulcer monitoring,
• implement state of the art signal processing and machine learning algorithms to increase the discrimination accuracy while maintaining hardware cost-benefit,
• 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 HOME version), and
• minimise operational cost in the monitoring and management of DFU.
The PHOOTONICS project delivered significant technical advancements, primarily through the development of the PHOOTONICS HOME and PRO devices. These devices incorporate state-of-the-art photonic technologies designed for the early detection and management of diabetic foot ulcers (DFUs). The key innovations include:
Advanced Sensing Technologies: The devices integrate multiple sensing modalities, including thermal imaging, hyperspectral sensing, and mid-infrared spectroscopy.
User-Friendly Design: Both devices were designed with user experience in mind, ensuring ease of use for healthcare professionals and potentially for patients in a home setting.
In short, the PHOOTONICS Solution:
• incorporates a novel HOME eHealth solution with intuitive interfaces that does not require highly skilled personnel for its operation, and it is able to output a scan of the full foot area in an acceptable timeframe
• can be deployed along with the PRO version in hospitals, small clinics and in the patient’s home, which can promote frequent use
• provides a rich, multi-layer dataset of qualitative and quantitative medical indicators for DFU monitoring
• delivers a first of a kind operational / methodological know-how based on the clinical study experience
The clinical validation phase was a cornerstone of the project, aiding in the successful integration and troubleshooting of the devices, and demonstrating their effectiveness in providing a multi-layered dataset.
Clinical Studies Across Multiple Sites: Clinical studies were conducted at leading European hospitals:
• Attikon University Hospital (Athens, Greece)
• Leiden University Medical Center (Leiden, Netherlands),
• Victor Babes University Of Medicine and Pharmacy (Timisoara, Romania),
with the valuable help of Charité University Hospital (Berlin, Germany)
The Study in all clinical settings managed to include a statistically significant pool of patients which was a necessary prerequisite for the validation of the devices.
Market and Exploitation Potential
The PHOOTONICS project not only achieved its technical and clinical objectives but also laid a strong foundation for future commercialization amd established a clear roadmap for the post-project phase:
Comprehensive Exploitation Strategy: A detailed exploitation plan was developed, focusing on the commercialization of the PHOOTONICS devices. This plan includes potential patent filings, market entry strategies, and the establishment of strategic partnerships with key industry players.
Market Readiness: The devices are well-positioned for market entry, with clear pathways identified for obtaining necessary regulatory approvals. The project’s outcomes also highlight significant market opportunities, particularly in Europe, where diabetic foot ulcers pose a major public health challenge.
Dissemination and Communication
Regarding the Dissemination and Communication activities, there were several activities performed:
The maintenance and update of the project website and social media channels i.e. LinkedIn, Facebook, and X. A series of promotional videos has been designed and delivered to explain in full detail the scope and purpose of the Project and the PHOOTONICS devices, as well as to showcase the commencement of the clinical studies in hospital settings. A total of thirteen (13) publications and articles have been published throughout the course of the project.
Advanced Sensing Technologies: The devices integrate multiple sensing modalities, including thermal imaging, hyperspectral sensing, and mid-infrared spectroscopy.
User-Friendly Design: Both devices were designed with user experience in mind, ensuring ease of use for healthcare professionals and potentially for patients in a home setting.
In short, the PHOOTONICS Solution:
• incorporates a novel HOME eHealth solution with intuitive interfaces that does not require highly skilled personnel for its operation, and it is able to output a scan of the full foot area in an acceptable timeframe
• can be deployed along with the PRO version in hospitals, small clinics and in the patient’s home, which can promote frequent use
• provides a rich, multi-layer dataset of qualitative and quantitative medical indicators for DFU monitoring
• delivers a first of a kind operational / methodological know-how based on the clinical study experience
The clinical validation phase was a cornerstone of the project, aiding in the successful integration and troubleshooting of the devices, and demonstrating their effectiveness in providing a multi-layered dataset.
Clinical Studies Across Multiple Sites: Clinical studies were conducted at leading European hospitals:
• Attikon University Hospital (Athens, Greece)
• Leiden University Medical Center (Leiden, Netherlands),
• Victor Babes University Of Medicine and Pharmacy (Timisoara, Romania),
with the valuable help of Charité University Hospital (Berlin, Germany)
The Study in all clinical settings managed to include a statistically significant pool of patients which was a necessary prerequisite for the validation of the devices.
Market and Exploitation Potential
The PHOOTONICS project not only achieved its technical and clinical objectives but also laid a strong foundation for future commercialization amd established a clear roadmap for the post-project phase:
Comprehensive Exploitation Strategy: A detailed exploitation plan was developed, focusing on the commercialization of the PHOOTONICS devices. This plan includes potential patent filings, market entry strategies, and the establishment of strategic partnerships with key industry players.
Market Readiness: The devices are well-positioned for market entry, with clear pathways identified for obtaining necessary regulatory approvals. The project’s outcomes also highlight significant market opportunities, particularly in Europe, where diabetic foot ulcers pose a major public health challenge.
Dissemination and Communication
Regarding the Dissemination and Communication activities, there were several activities performed:
The maintenance and update of the project website and social media channels i.e. LinkedIn, Facebook, and X. A series of promotional videos has been designed and delivered to explain in full detail the scope and purpose of the Project and the PHOOTONICS devices, as well as to showcase the commencement of the clinical studies in hospital settings. A total of thirteen (13) publications and articles have been published throughout the course of the project.
The final phase of the Integration and the Clinical Validation has justified the original PHOOTONICS concept, since all the Call challenges set by the European Commission have been met.
The results of the study were utilized by the project's technical partners to enhance and optimize the sensing/photonic interfaces, aligning with the project's core objective of advancing the state-of-the-art. Through this iterative process, the technical partners have continuously refined and adjusted the integrated system's components, effectively navigating and overcoming any encountered challenges.
The competitive advantage of the PHOOTONICS solution demonstrated in this validation phase is based on three key factors: a) the use of multiple data sources through integrated photonics technologies, b) the unique set of biomarkers collected, and c) the comparison between HOME and PRO datasets.
Overall impact
The successful completion of the PHOOTONICS project represents a significant step forward in the management of diabetic foot ulcers. By enabling earlier detection and more effective management, the PHOOTONICS devices have the potential to reduce the incidence of severe DFU complications, improve patient quality of life, and reduce healthcare costs associated with long-term DFU treatment.
The results of the study were utilized by the project's technical partners to enhance and optimize the sensing/photonic interfaces, aligning with the project's core objective of advancing the state-of-the-art. Through this iterative process, the technical partners have continuously refined and adjusted the integrated system's components, effectively navigating and overcoming any encountered challenges.
The competitive advantage of the PHOOTONICS solution demonstrated in this validation phase is based on three key factors: a) the use of multiple data sources through integrated photonics technologies, b) the unique set of biomarkers collected, and c) the comparison between HOME and PRO datasets.
Overall impact
The successful completion of the PHOOTONICS project represents a significant step forward in the management of diabetic foot ulcers. By enabling earlier detection and more effective management, the PHOOTONICS devices have the potential to reduce the incidence of severe DFU complications, improve patient quality of life, and reduce healthcare costs associated with long-term DFU treatment.