Work Package 5
Production of advanced prototypes to be marketed.
The smartphone applications A1 and A2, as well as the specific foot pad will address several medical objectives: additional tool to detect hyperthermia, help in the prevention of DF ulcers, evaluate ulcer status during its treatment and contribute to the healing of DF ulcer. They will be tested in real clinical situation and improved taking into accounts remarks of the users (medical staff, university members and patients), to result in advanced prototypes.
To that end, we will have to collect and compile the needs of the DF medical staff and patients, to propose a feedback to the different entities in charge of the WP1, WP2, WP3, WP4 and WP5.
The solutions developed aim to be commercialised as medical devices for diagnosis support and DF care. In this way, the CE/FDA certification constraints will be anticipated.
Different regulatory documents will be considered:
- Customer specification requirement (design brief elaboration).
- Risk analysis.
- List of standard to be considered for this application.
- Compliance to essential requirements (Directive 93/42).
- CE/FDA certification process.
- Usability evaluation.
These documents will be updated and taken into account all along the STANDUP project in order to consider the possibility to quickly bridge the gap between these advanced prototypes and their dissemination to the market thanks to companies involved in the STANDUP project.
The targeted end users will be different regarding the various results:
- Application A1 to detect hyperthermia: in a first step it will be dedicated to medical staff specialized in DF (diabetologists, specialized nurses and podiatrists). In a second step, medical staff at large will be of interest (mainly medical staff in medical centers), and finally DF patients for at-home prevention of DF ulcers.
- The advanced tool composed of application A1 associated to the regional analysis and thermal stress for a better prevention of DF ulcer and treatment. This advanced analysis will be dedicated to the medical staff only, first to specialists of DF, and second to general medical staff.
- Application A2 (evaluation of ulcer evolution) for specialized medical staff in hospitals, in a second phase to general medical staff.
- Specialized foot pad design for podiatrists only.
Information produced during the analysis of the thermal images is to be shared. Thanks to the use of smartphones in the whole project, this will be an easy task for the user. In this WP, a first solution to share data in a secure and efficient way will be developed to:
- Easily and securely exchange information with other clinicians, including those in other specialties.
- Electronically exchange information with other health care and administrative organizations.
- Electronically deliver secure guidelines and provide quality and individualized care with immediate access to the patient’s health history.
- Accommodate the wide variety of technological infrastructure employed among different clinical settings.
Jointly, STANDUP will design of the framework necessary to ensure that health care providers from different locations, specialties, and organizations areto be able to work together to provide appropriate care interventions or recommendations when the DF patient requires them. It will also enable the patient to access and coordinate his own health information and status for a better involvement in the treatment procedure and thus for better health outcomes. As the web browser provides a widely accepted and nearly universally available vehicle for presentation and delivery of content, providing ease of access to information, while using a wide variety of computer equipment,, it will constitute the base of the interoperability system.
In addition to DF, we will also explore the possibility to use the thermal tools developed in the project to other medical domains as for example the early detection of breast cancer. Breast cancer is a major public health problem responsible for one in six deaths for women. At present, there are no effective ways to prevent breast cancer because its cause remains unknown. Systematic mammography screening for women over 50 years of age is essential in reducing mortality. However, there are 25% of breast cancers diagnosed before this age. A reliable diagnosis in its early stages can offer women a better chance of complete recovery. In the early stages of the cancer, new vessels increase the blood flow in the region, causing an increase in temperature. In breast tumors, this increase in local temperature can be observed at the surface of the breast through the images captured by a thermal camera. These reasons make that the tool developed during STANDUP could be adapted to that problem. WP5 will explore the adaptation of the tools developed in WP1 and WP2 for breast cancer screening for women before the age of 50 years. Especially, software A2 (Smartphone application to assess variations of an ulcer of the plantar foot surface temperature along time during treatment of ulcer), which allows to have thermal information in 3D will be tested in a small clinical trial defined during the project.Back