There are over 420 million diabetics in the world, of which one million lose a leg — as in, have it amputated — every year. That is, one person loses a leg every 30 seconds to diabetes somewhere in the world. India has some 65 million diabetics; you do the math on how many among them undergo amputations every year.
A Bengaluru startup, Yostra Labs wants to try and reduce the number of diabetic amputations with two products aimed at diabetes foot care.
Foot care is especially important for diabetics because they are at a risk of developing serious infections even from small ulcers or injuries that could lead to gangrene and subsequent amputation. Long years of poorly controlled diabetes causes nerve damage (called neuropathy) that lowers the sensitivity in the feet raising the risk of injury. The injury takes long to heal because of reduced oxygen flow to the affected part due to blood vessel damage, common among diabetics of long years.
Long years of poorly controlled diabetes causes nerve damage (called neuropathy) that lowers the sensitivity in the feet
Yostra has developed two devices: ‘Sparsh’ and ‘Kadam’. While Sparsh will screen diabetics to determine if they are at risk of developing nerve damage, Kadam promises to accelerate the healing process of feet ulcers in diabetes patients.
Sparsh is a hand-held device, the size of a hair trimmer and Yostra claims it is the only device that combines all the three tests of touch (tactile threshold test), vibration (vibration perception threshold test), and temperature (thermal perception threshold test) to gauge nerve damage.
“The touch test is done completely manually by others which is totally subjective, whereas ours is an electronic device that automatically tells the exact amount of pressure via our smartphone app,” says Vinayak Nandalike, CEO and Founder, Yostra. This helps in accurate diagnosis, he adds.
The clinical trials will start in September and the product is expected to be in the market by the end of the year. Sparsh will be launched in partnership with UK-based chain of diabetes clinics Diabetacare which has 25 centres across India.
The right foot forward
Current day diabetic foot ulcer treatment has the patient sitting in what is called a hyperbaric oxygen therapy chamber or tube, much like the decompression chambers that deep sea divers use. Air pressure is increased to three times normal air pressure that results in more oxygen being absorbed by the lungs and reaching all parts of the body, including feet, through blood. Better oxygenation of the ulcer means faster healing.
However, this is an expensive procedure, and requires the patient to travel. The chamber that pumps in oxygen costs around Rs 70 lakh and each session makes a patient poorer by about Rs 5,000.
“Kadam isolates the treatment area only to the leg. It’s completely portable and the treatment can be given at home,” Nandalike says.
The cabin bag trolley-sized device consists of an oxygen concentrator and a therapy chamber. The therapy chamber is a plastic bag the patient has to wear (it reaches up to the knee). The bag self inflates because of the oxygen being supplied and the oxygen is supplied at an elevated temperature (43 degree Celsius) which accelerates the healing.
“The oxygen actually helps in killing the anaerobic organisms around and the treatment can be given at home. We dilate the blood vessels with warm oxygen and we give an oxygen mask to increase the oxygen saturation in the blood,” says Nandalike.
The cabin bag trolley-sized device consists of an oxygen concentrator and a therapy chamber.
The clinical trials for Kadam were conducted at the Vydehi Medical College, Bengaluru. “In some patients we are able to increase the blood supply by 300% and in others 100%,” says the Yostra CEO.
Kadam, too, like Sparsh, will hit the market by the end of the year. While Sparsh will be priced Rs 15,000 upwards, Kadam will cost around Rs 2 lakh.
According to Dr Sunil Joshi, Associate professor of surgery, St John’s Medical College Hospital, Bangalore, who has been treating patients with diabetic conditions for the last 16 years, 25% of diabetics suffer from foot ulcers during their lifetime and are at the risk of losing their legs.
“Majority of amputations begin with a small ulcer (85% cases) often due to neuropathy. Prevention of this challenging condition is crucial and can be done only by creating awareness, early screening to detect people at risk and providing affordable treatment for diabetic foot ulcers in early stages,” says Dr Joshi.