CHENNAI: India ranks second in the world with 65.1 million persons with diabetes, of which 9.75 million (15%) suffer from diabetic foot ulcers and run a high risk of lower limb amputation. Currently, there is no device in the country that would avert this. However, scientists of the Central Leather Research Institute (CLRI) along with MV Hospital for Diabetes, Royapuram, claim to have developed special affordable footwear that will heal foot ulcers faster, reduce chances of amputation.
Diabetic foot ulcers are predominantly caused by repetitive stress over an area that is subject to high vertical or shear stress in patients with peripheral neuropathy. This new footwear called Ankle-Foot Orthosis (AFO) is an off-loading device that redistributes the plantar pressure. Plantar pressure offloading in the affected foot at the ulcer site is a very important aspect of wound healing.
Scientists claim patients using AFO can get rid of 'highly-problematic' foot ulcers within three months and can lead a normal life. The footwear's patented insole is designed in such a way that it provides extra depth and accommodates the wound without coming in direct contact. The entire item will tentatively cost around `3,000.
G Saraswathy, project in-charge and scientist at Shoe Design and Development Centre at CLRI, told Express that six product prototypes are developed in standardised sizes for both male and female use. "We will be testing the footwear on select patients of MV Hospital for Diabetes and also the general hospital. The ethical committee of MV Hospital has given its approval."
Scientists said, before arriving at the design, gait analysis was conducted on persons with diabetes, diabetic neuropathy and diabetic foot ulcers. "CLRI has the first-of-its-kind full-fledged gait analysis laboratory in the country. Gait abnormality is reported in patients with diabetes. The neurodegenerative process is accelerated in diabetes resulting in declining motor control, postural stability/foot posture and abnormal weight bearing in the foot.
The system gauges the level of efficacy of the developed AFO in bringing normalcy to the gait of the affected person. The AFO has been designed based on gait alterations in persons with diabetes in comparison to those that are non-diabetic," Saraswathy explained.
Foot pressure, shock and shear can be reduced with appropriately fitted AFO and customised insoles. Saraswathy said the material that is used in the AFO makes the treatment cost-effective and, therefore, affordable to patients in India.
Physiotherapist Satish Babu and senior research scholar Priyadarshini, who are part of the product development, said the main advantage of this product is it is removable. Currently, a unremovable POP total cast is used on patients with diabetic foot ulcers. "Patients have to take complete rest. However, this device is removable. Within three months, the ulcer will heal," they said.
MV Hospital's head & chief diabetologist, Dr Vijay Viswanathan, who is also the co-principle investigator, said the product will bring great relief when it's fully developed and tested. "We don't have special footwear such as this in India. There are imported products which are highly expensive and not easily available. Our idea is to develop an affordable product for Indian patients. At MV Hospital, I can get some imported insoles from Germany, Italy and United States, which cost nothing less than `2,000 each."
No other Indian product
In India, an irremovable POP total contact cast is used for offloading diabetic foot ulcer (DFU). No removable device is available commercially.
Similar products available in the market
Ottobock India is selling a walker boot which can immobilise the foot and ankle for healing Achilles tendon ruptures, forefoot or midfoot fractures, ankle fractures, distal fibula fractures, soft tissue injuries, post-operative use, trauma and rehabilitation. This is also used for healing DFU by few diabetologists in India. The product costs around Rs 20,000. Diabetic Pneumatic Walker, (USA: unit price $190) and Rebound Diabetic Walker, (Canada: unit price £25) are available online.
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