The number of patients who need lower limb orthotics is increasing day by day, especially with lower limb functional disability. No study about the role of orthosis in the management of lower limb functional disability under went in our country. For better management of patients’ condition further research on this aspect is highly needed.
Orthosis is one of the most important components of rehabilitation of patients with locomotor disability. An orthosis is defined as a device that is attached or applied to the external surface of the body to improve function, restrict or enforce motion or support of a body segment. Orthosis are used for straightening bones, but they also prevent deformities, alleviate pain, protect limbs, promote osteogenesis, and strengthen the limbs as well as spine.
Orthoses are required when the following condition arises,
India is referred to as the capital of type 2 diabetes. The burden of diabetes as well its complications like the diabetic foot is increasing constantly. The diabetic foot is frequently a slow-to-develop, painless surprise. It leads to disability, long stretches of hospitalization, mounting costs, and often, amputation. Once patients receive a limb amputation, they may suffer further problems of pain consequent to a phantom limb that is often very difficult to manage. India currently leads the world with an estimated 40.9 million people with diabetes; this figure is predicted to increase to 69.9 million by 2025. The diabetes epidemic is more pronounced in urban areas in India, where prevalence rates of diabetes are roughly double than those in rural areas.
DiponEd is collaborating with IIT Hyderabad to develop 3D printed personalized orthotics of the lower limbs. The project is supported by the Uchhatar Avishkar Yojana, Ministry of Human Resources Development, India. The project was selected through screening of Domain expert committees. About 90 projects were selected from a total of over 180 proposals from different IITs. Dr. Falguni Pati & Dr. Subha Narayan Rath would lead the team at IIT Hyderabad.
Indian market, and along with other DIPONS products for treatment of Diabetic foot ulcers, it is set to protect patients from amputations and also offer faster recoveries. In India, the clinical profile of diabetic foot differs and is influenced by such factors as the practice of walking barefoot or wearing inappropriate footwear, illiteracy, faith in alternative system of medicine, and the lack of training of primary care physicians in the treatment of the diabetic foot. Dr.Kaushik D Deb, CEO of DiponEd Biointelligence, a personalized medicine company said “This is a 1 st of its kind technology”. Although recent population based data are not available, it is estimated that approximately 45 000 legs are amputated every year in India. The vast majority (75%) of these are probably preventable because the amputation often results from an infected neuropathic foot. In India, the concept of “team approach,” which is essential for the successful management of the diabetic foot, is just gaining acceptance. A clear understanding and acceptance of responsibilities for managing the infected diabetic foot often leads to delayed action and this in turn may affect limb salvage. The amputation of lower limb could be easily be avoided by proper designing and manufacturing of personalized orthotics. In fact, by proper designing of the orthotics, the disease progression can also be retarded and also be reverting back to the original state.
However, there is no manufacturer in India who offers personalized orthotics to these patients. DiponEd a personalized medicine company and partner’s will produce the orthotics and market them upon completion of this project. Most of the orthotics are imported from abroad, but could not support proper fit and comfort. Hence, there is a huge scope for developing indigenous personalized orthotics. The advent of 3D printing technology is a boon for manufacturing industry as custom-made, complicated 3D structure can be produced by this technology. We would develop novel technology based on 3D printing for rapid manufacturing of lower limb orthotics. For first prototype, we will focus on developing orthotics for diabetic foot ulcer patients.
Industry partner, DiponEd BioIntelligence will manufacture the 3D printed orthotics & conduct a clinical study for diabetic foot ulcer to make a patient information system (PIS) as there are no such system exists. We will start with a pilot study and extend it to over multiple centers quickly. Industry partner will also collaborate with clinicians and orthotists for getting their advice and comments for developing PIS and orthotics. DiponEd BioIntelligence will involve in and support the clinical translational.