The University of Wales Trinity Saint David’s (UWTSD) Assistive Technologies Innovation Centre (ATiC) has recently completed a collaborative pilot study with Swansea-based Kaydiar Ltd, which specialises in offloading (reducing pressure) technology for pressure lesions on the foot, from diabetic care to sport footwear.

The study assessed direct pressure redistribution on a selected area on the plantar foot using the company’s ZeroSole silicone, modular design insole, which can be placed in conventional footwear, to help treat and prevent everyday painful pressure-induced foot lesions for end users.

The study was facilitated through the £24million Accelerate Wales programme, which is led by Life Sciences Hub Wales, co-funded by the European Regional Development Fund (ERDF) through Welsh Government.

The ZeroSole insole is designed to aid pain management and plays an integral role in the treatment of pressure-induced foot lesions, such as the common heloma durum, through offloading.  Offloading is a treatment intervention which is universally recognised and adopted by healthcare professionals.

The insole’s innovative modular design allows sections of the insole to be permanently removed at the location of the lesion, aiding pain relief and preventing lesion reformation.  ZeroSole’s intended use is only for low-risk pressure-induced foot lesions, such as corns and callosities.

The ZeroSole insole is versatile and fully customisable, allowing it to offloading any, or multiple sites of the foot which are affected by pressure-induced lesions. This therefore acts as an immediate therapeutic treatment for such lesions; and is made accessible to the general public.

Due to its long-life span, this creates a cost-effective device, which not only treats but helps to prevent these recurring lesions.

David Barton, Co-founder and Co-Chief Executive Officer of Kaydiar, said: “Kaydiar approached ATiC, through the Accelerate programme, for its expertise to assist us to develop the ZeroSole insole in readiness for market launch, and to capture data for comparative analysis and new product development.

“The pilot study aimed to evaluate the ZeroSole by assessing pressure redistribution data relating to the offloading area.

“When fully developed, which we anticipate being in February 2023, our product will be the first offloading, silicone, modular insole to bring about effective custom offloading for ordinary footwear in the over-the-counter pharma (OTC-pharma) market for painful pressure-induced foot lesions, such as the heloma durum.”

Dr Yajie Zhang, ATiC Innovation Fellow at UWTSD, said: “The study used a blend of research tools located in ATiC’s state-of-the-art User Experience (UX) laboratory, including F-Scan in-shoe pressure mapping to capture foot pressure data, synchronised with a motion capture system for gait video. UX was also captured.

“The research aimed to explore the effectiveness of the ZeroSole insole with a sample group of healthy participants, gender balanced, with various feet sizes, as a step to check the insole’s offloading effects.”

ATiC tested participants’ walking in four ways: wearing their normal footwear without ZeroSole; with ZeroSole but without removing modules; with ZeroSole and removing modules on one insole; with ZeroSole and removing modules on both insoles.

The location of the removed modules, i.e., cavity, was under the second metatarsal-phalangeal joint, standardised for each healthy individual.

“The study indicated that wearing ZeroSole insoles not only successfully offloaded the target area when compared to wearing normal insoles in the participants’ footwear, but also cushioned the whole foot, without changing the participants’ basic gait parameters,” added Dr Zhang.

“Working with ATiC and its partners, future research opportunities may facilitate Kaydiar’s products to be evaluated clinically, and potentially with patients who are receiving care for the management of musculoskeletal disorders of the foot and lower limb,” said David Barton.