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Diabetics suffering from foot ulcers are in a greater risk of having to go under lower limb amputation. MoveSole Smart Insoles help healthcare professionals by measuring the effectiveness offloading at the clinics and outside with everyday usage.

For a long time now, Healthcare professionals have been looking for a reliable method to measure and analyse gait while people walk in their natural environment vs. clinical settings. And this is precisely why MoveSole Ltd was established. Now after three years of collaboration with healthcare professionals on development and piloting, the MoveSole Smart Insole is being finalized to get the medical device approval and is ready for sales. Because of this development work, we now have an excellent tool for the healthcare professionals to treat foot ulcers and lower limb injuries both in the clinics and outside. Since the beginning of MoveSole Smart Insole development all selected technologies have been harnessed to deliver a solution for precise and easy gait measurement.

MoveSole Smart Insole is a perfect fit to the professional demands on ulcer treatments

It has been estimated that there will be over 640 million diabetics in 2040 globally (source). In Finland, about 10% of the population is diabetic (source in Finnish). Foot ulcers caused by diabetes result in more clinical visits than any other diabetes related health issue. While suffering from diabetes, the risk of getting ulcers grows hand in hand with the diabetes induced neuropathy, which in turn results in loss of sensation and nervous system complications. One of the key methods of foot ulcer treatment is to offload weight from the ulcer infected area. This is usually done with special offloading shoes and/or insoles. The offloading treatment aims to stop the ulcer from growing bigger, which in the worst case could lead to a lower limb amputation. Until now the healthcare professionals have been lacking a method or a device to measure the offloading insole’s effectiveness. So far the patients have received offloading aids that have been built on rough visual estimations, while requiring plenty of patient generated feedback, which might be problematic due to the diabetic neuropathy and impaired sensation.

With the MoveSole Smart Insoles it is now possible to reliably analyse how the tailored offloading is working and whether the weight has been directed away from the right spot. At a clinic, the foot therapist places the MoveSole Smart Insole under the offloading insole, which has been designed for each diabetic patient separately. Then the therapist can detect how well the offloading works as the MoveSole Smart Insole sends gait and weight distribution data to a mobile application while person wearing it is walking.

The professionals who treat foot ulcers have been lacking monitoring tools for both at the clinics and outside of them. There’s a big difference on how people walk in a natural setting by themselves versus a carefully monitored short walking session by a therapist.

The biggest issue has been to verify that the ulcer area is truly exposed to less pressure with the offloading insoles people are given. The diabetics themselves cannot verify this due to the lost nervous system capacity and loss of sensation caused by diabetic neuropathy. Commonly, the neuropathic loss of sensation starts from the feet and this in turn increases the risk of getting ulcers noticeably. Therefore, IWGDF (The International Working Group on the Diabetic Foot) as an important independent organisation, recommends careful monitoring of treatment related offloading.

MoveSole Smart Insole: Laboratory level measurement both at the clinics and outside

Thanks to the MoveSole Smart Insole health professional can assess already at the clinic whether the pressure has been offloaded from a targeted spot. As a part of ulcer treatment, a diabetic should wear the personally tailored offloading insole for the whole period of care, which might take more than three months. Currently, the effectiveness of care is being evaluated in every two weeks at a visit to the clinic.

The MoveSole Smart Insole can also be used outside the clinics under the supervision of foot therapy professionals: this will generate data regarding offloading effectiveness also in between the clinic sessions. This in turn provides a much greater amount of gait data and ensures the reliability of monitoring. The data collected by the MoveSole Smart Insole gives direct evidence to the care professional on how the patient has been walking and whether the offloading has been correctly positioned. Since the MoveSole Smart Insole is light and durable, it can be easily used under the supervision also in the home environment.

MoveSole Smart Insole is durable and easy to use

With MoveSole Smart Insole, ease of use has been the key design principle since the beginning of the product development. Healthcare professionals need tools that are easy and fast to use. So far foot care professionals have been given tools that require up to 10-15 minutes setup time, which consumes a notable part of the actual appointment. Whereas MoveSole Smart Insole can be taken into use in less than one minute.

All the MoveSole Smart Insole collected data is visualised in the mobile application, which has been designed solely for this purpose and has a very visual user interface to support care. This application collects all walking related data and creates reports to support care effectiveness monitoring. These reports can be used at any given time, which helps long term monitoring. The data analysis is easy regardless if one is interested in a specific gait detail or on the overall picture.

Gait monitoring in an everyday life of a diabetic will become a norm in the future of foot ulcer care

Drastic measures such as foot amputations, can be minimised with efficient foot ulcer prevention and care. Diabetics are in a 15 times bigger risk to undergo a foot amputation when compared to other population (source in Finnish). Moreover, 50% of the foot ulcers renew (source). Annually, in Europe the total number of foot ulcer related amputations is close to 500,000 (source).

Current medicine should not just rely on a visual evaluation of the professional when monitoring and evaluating foot ulcer care and the effectiveness of offloading. By harnessing technology to the care process, we can continuously monitor the patients’ advancement instead of seldom control points at the clinics. Based on the timely information collected with the MoveSole Smart Insole, the healthcare professionals are better equipped to treat foot ulcers. Preventive care will become more important in the future and the MoveSole Smart Insoles can also be used to monitor the pressure around already a healed ulcer, just to make sure that the condition will not return.

MoveSole Smart Insole is a versatile healthcare monitoring device

In addition to diabetic foot ulcer offloading treatment, the MoveSole Smart Insole can be used in various other ways in healthcare, e.g. it can be used with leg injury patients to analyse the pressure caused by walking and to teach correct way of setting pressure to the injured limb plus monitoring and teaching the symmetry of walking for those who are recovering from leg injuries. Besides fractured bones such injuries can be ligament injuries. At the moment, the MoveSole target audience consist of diabetics with foot ulcers and patient recovering from lover leg injuries, though naturally this product can be applied to various other forms of physical rehabilitation.