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Smartphone Thermal ANalysis for Diabetic foot Ulcer Prevention and treatment

Periodic Reporting for period 1 - STANDUP (Smartphone Thermal ANalysis for Diabetic foot Ulcer Prevention and treatment)

Reporting period: 2018-01-01 to 2019-12-31

What is the problem/issue being addressed?
Type II diabetes, or simply diabetes, is a major public health problem that is increasing dramatically. Diabetes related diseases mainly affect the foot, the eyes, the heart, the kidney, the nervous system, and blood vessels. The STANDUP project will focus on diabetic foot (DF). DF diseases include neuropathy, peripheral arterial diseases, and infection. In the presence of a triggering factor, it may lead to ulceration and subsequent lower limb amputation. Skin temperature is not currently well exploited even though it is an important factor in the evaluation of foot health and can strongly reduce the incidence of foot ulcer. There is a significant potential for the development of system to reliably detect abnormal thermal variations of the plantar foot in clinical routine or even at home. Insoles have been used extensively in the past to decrease the risk of foot ulceration, but the foot thermoregulation has not been established.

Why is it important for society?
Considering the number of people living with diabetes in Europe (EU-27) and the annual population based ulceration rate this implies that nowadays 600,000 diabetic foot ulcers occur each year of which 90,000 will require an amputation. It is estimated that the average treatment cost for a single diabetic foot ulcer is about 10.000 EUR. The direct annual cost of ulceration is estimated to be of 15 Billion EUR. In the future, associated costs in terms of quality of life and health as well as sociable care expenditures are expected to rise leading to significant associated morbidity and mortality in DF if no measures are taken.

What are the overall objectives?
The overall objectives of STANDUP are to develop, test, improve and disseminate to the market in a very near future a thermal based smartphone system for DF. This friendly system will detect abnormal thermal variations in DF plantar surface, will give thermal information during a DF ulcer treatment, and will help in developing new insole that take thermal information into consideration. This system is composed of a smartphone, of a dedicated thermal camera and of two smartphone applications A1 and A2. These 2 smartphone applications will be developed during STANDUP.
The 5 operational objectives of STANDUP are as follow.
1. The first smartphone application (A1: hyperthermia detection and analysis of thermal variations through time) will permit to detect hyperthermia of the plantar foot surface.
2. The second smartphone application (A2: time follow up of temperature, color, and 3D shape of DF ulcer) will measure temperature, color, and 3D shape of an ulcer along time.
3. In the STANDUP project, we propose to take into account thermal factors for a design of new foot insoles.
4. Three clinical studies will be conducted.
5. Finally, all results produced during STANDUP will be associated to converge in an advanced smartphone based prototype and in new insoles that can rapidly address novel market demands in early DF diagnosis, and in DF ulcer prevention and care.
Standup is structured in 7 Work Packages (WP):

WP1: Project management
During these 2 first years of STANDUP, the management was mainly about participating to the Coordinators day in Bruxelles, organizing the kick-off and mid-term meetings, and developing the STANDUP web site.

WP2: Smartphone application A1 to detect hyperthermia and do regional thermal analysis of the plantar foot surface
An artificial Intelligence method using deep learnnig (Seg-Net) has been developed and validated. A pilot android version of A1 was developed.

WP3: Smartphone application A2 to assess variations of an ulcer of the plantar foot surface temperature along time during treatment of DF ulcer
WP3 will examine temperature, colour, and 3D shape of diabetic foot ulcer along time. Ulcer assessment was designed after segmentation of the images using deep learning approach (U-Net). As for application A1, a pilot version on android is available.

WP4: Improvement of insole using thermal information
A variation of the viscoturf was further modified to accommodate the requirements for thermal characteristics of the insole. Tests have indicated that the viscoturf inspired insoles can reduced the foot temperature immediately after use more effectively compared to the conventional insoles.

WP5: Clinical trials for the analysis of thermal variations of the plantar foot surface in DF
The cold stress test clinical trial was done in the Hospital National Dos de Mayo (HNDM) in Lima, Peru. This clinical trial involved 138 diabetic person that came in the HNDM for diabetic problems.

WP6: Advanced prototypes
The smartphone applications A1 and A2 as well as the specific foot pad, will address several medical objectives to result in advanced prototypes.

WP7: Communication, dissemination and exploitation
The following dissemination and communication activities have been developed during the reported period: the STANDUP logo, the STANDUP Web site, and Twitter activities.
Progress beyond the state of the art
STANDUP presents a novel approach to characterize and represent pathological symptoms in DF, using smartphone thermal images. STANDUP intends to go one step forward by offering a direct support to the medical staff and to the patient via a smart media. Such support will range from the displaying of meaningful health information related to foot temperature, of individualized foot pad, as well as the possibilities of sharing information. This novel and original concept should enable:
- a more accurate diagnostic of the DF from its early stage,
- a better follow-up and prophylaxis of the disease,
- a better interaction between DF patients and the medical staff,
- a better management of the DF patient.

Such approach should thus significantly contribute in:
- optimizing medical interventions,
- strengthening evidence base on accurate medical outcomes,
- improving the productivity of healthcare systems,
- facilitating DF patient care at the point of need, health information processing and quicker transfer of knowledge to clinical practice.

Expected results until the end of the project
The overall objectives of STANDUP are to develop, test, improve and disseminate to the market in a very near future 2 smartphone based system to assess hyperthermia in DF, to follow in an efficient way DF ulcer during treatment, and to improve the conception of foot insole and the choice of personalized foot pad using thermal information.

Potential impacts (including socio-economic and societal)
Precise economical impacts of STANDUP have not been evaluated yet. However, 500 million of diabetic persons are expected in 2030 worldwide. STANDUP will result in a friendly, efficient and low cost system that can be used in every hospital, clinical center or even at home in DF prevention and follow-up. The economical impact of STANDUP in case of great success could be of a very high level.
Considering social impact, 60 Million of people in Europe are suffering from type II Diabetes and 600,000 DF ulcers occur each year leading to 90,000 foot amputations. It is estimated that the annual cost of ulceration is 15 Billion EUR. STANDUP will reduce the number of DF, and will reduce DF complications as foot ulcers. Finally, STANDUP can reduce distress, minimize symptoms and, ultimately, improve prognosis. It will lead to economic benefits for social and healthcare system.
Acquisition of a thermal plantar foot image with a smartphone and a themal camera
A typical plantar foot thermal image of a DF patient