Dr Jacopo Secco, Politecnico di Torino; Dr Marco Farina, Politecnico di Torino
A cutaneous chronic wound (or ulcer) can be defined as one that has proceeded or failed the repairing process without establishing sustained anatomic and functional results in a period of 3 months.
The National Center for Health Statistics (NCHS) declared that in most cases the complete healing, if reached, may require several years or even decades. Severe pain, reduced mobility, loss of independence, significant emotional and physical distress is just some of the main aspects that associate people living with a wound.
Moreover, additional emotional and physical trauma comes from the high risk of amputation and mortality. Ulcers precede 85% of all amputations (diabetic ulcer is the reason for 70% of all lower limb amputations) and the 5-year mortality rate following amputation is reported to be between 40 and 70% and is even higher among patients with major amputation.
It is claimed that wound treatment and care accounts for 6% of National Health Service (NHS) expenditure (US$40 billion per year between US and Europe). Therefore, it is of absolute priority to make a change in the way we consider the wound care management to reduce healing times and improve the quality of care. Unfortunately, events such as infections, amputations and death as a consequence of the wound development are still crucial problems and may be avoidable with a more accurate monitoring of the healing process.
In order for the wound to heal, patients need to be continuously monitored by physicians (around once every two weeks) and the medication has to be changed according to the healing status.
Our solution is called Wound Viewer (WV). Wound Viewer is a Class 1 medical device able to acquire and automatically process wound images through an artificial intelligence (AI) algorithm providing to the physician fundamental parameters such as area, depth, recognize the tissue composing the wound (example: granular, necrotic), wound exudate and the presence of deadly infections. All this in just a couple of minutes and the data are automatically stored in a Cloud platform and remotely accessible to the physician.
Several studies estimate that about 8% of the whole EU health expense budget, over the following five years will be allocated to wound care and about 50% of local nurses’ interventions will be wound care-related. According to several reports, the European Advanced Wound care market has been estimated at €2.5 billion in 2015 and is projected to reach €3 billion by 2020 (second largest market for Advanced Wound care products, after North America). The European market is mainly segmented geographically (Germany, France, Spain, Italy, U.K, and others) and its growth is driven by several factors such as the increase of the mean population’s age and the increase of cases of diabetes (also in younger population with age less than 40) which are universally recognized as direct causes for Chronic Wounds, technological advancements and encouraging government policies.
The wound monitoring device market is the fastest growing segment in this category (Europe and Asia Pacific are collectively expected to account for over 45.4% of the total digital wound measurement devices' market share). The necessity for advanced technologies to monitor the progression of wound healing is driven by the need of reducing healing time, complications risk, hospitalization costs, providing to the wound specialists a tool able to detect the healing process and make them realize the effectiveness of the therapy.
The Wound Viewer device and system has been fully developed.
Software reliability was tested in Q4 2016 on over 400 patients reaching a 94% ± 4% of measurement accuracy (vs. 60% of current standards).Thanks to the outcomes of this testing a clinical trial has been started on 150 new patients at the Clinica San Luca (Turin).
A priority application has been filed on December , 2015. Another priority application has been filed on 2017.
Wound Viewer is a system with a different market positioning compared to the competitors. WV is the only system that employs an artificial intelligence algorithm that in just few minutes and by clicking just one button, automatically recognizes the ulcer in the acquired pictures and provides an accurate valuation 3D measurement of several advanced wound parameters such as: area, depth, tissue granulation, presence of exudate wound and the infection score.
Then, the WV system is able to fill up the patient’s digital folder and graphically shows the trend of the healing over the time. No further actions are required by the user.
Hardware Device (A): Class I device for the acquisition of wound pictures maintaining always the same boundaries conditions (light intensity, distance to the wound always known, quality of the pictures). Distance, infrared, gyroscope and humidity sensors are implemented to provide the highest accuracy. A simple camera or smartphone is not sufficient for collecting all the required data.
Application (B): The Mobile app, designed in collaboration with wound care specialists, represents the evolution of the lesion with a user-friendly graphic representation.