INSIDE SCOOP

So what generally will I be doing?

All throughout my orientation here at Fulbright, I've gotten to interact with countless Fulbrighters as we exchange sparknotes on where we'll be and what we'll be doing through Fulbright. Trust me when I say not a single elevator pitch I've heard has been anything short of amazing. Here's my Elevator pitch: I'll be working on a wearable diabetic technology that helps with the management of diabetic foot ulcers. They form in the later stages of diabetes but account for a majority of amputations worldwide when they go untreated. The goal of the device I'm building is to be a low-cost solution to first study the problem, then to be able to diagnose the ulcers, and finally to be used as a therapy device to heal the chronic problem.

Want more details? Here's what I submitted to Fulbright trying to convince them to let me come to India!

Untreated foot ulcers resulting from diabetic neuropathy are responsible for 85% of non-traumatic amputations worldwide. Diabetes is rapidly becoming an international epidemic as its prevalence has nearly quadrupled since 1980 and is expected to exceed 640 million cases by 2040. India, now being called the "Diabetic Capital of the World," is home to 20% of the world’s diabetics - the largest per capita according to the World Health Organization. It is estimated that as many as 50% of cases are undiagnosed in rural areas of India, making the actual number even higher. I propose to design low-cost instrumentation to study the physiological changes of pressure, temperature, and blood flow leading up to diabetic ulceration, and to develop the instrumentation into a wearable therapy device.

Every thirty seconds a major limb amputation is performed as a result of a diabetic foot ulcer. Diabetic ulcers develop if neuropathy, death of nerve cells in the hands and feet, sets in as it does for 90% of patients who have lived with diabetes for 20 years. The diabetic complication of vascular occlusion, the reduction of blood flow reaching the capillaries of bodily extremities, further exacerbates the progress of neuropathy. Neuropathy begins with sensory loss; consequently, patients become unable to feel pain in their feet. Loss of protective tactile feedback causes imbalance and a compromised gait. Repeated acute pressure on the foot induces calluses that develop into plantar ulcers and, if left untreated, become vulnerable to infection since the immune system is often compromised in diabetics. If gangrene sets in to the infected ulcers, the limb is often deemed unsalvageable and requires amputation.

Practitioners such as Dr. Nihal Thomas at India’s CMC Vellore Hospital have studied genetic predispositions and environmental factors that lead to foot ulcer progression in diabetic patients. It is understood that ulcers begin to heal once the repeated pressure is offloaded, but instrumentation to study how acute pressure affects ulcer development is insufficient. Many Indian endocrinologists use the Harris Mat to study plantar pressure; the mat, an ink roller and paper, gives graphical display of high-pressure points depicted by increased intensity of inked regions. These static plantar pressure readings do not give insight concerning weight distribution as the patient walks or runs. Force plates enable satisfactory gait analysis, but the hardware is expensive, cannot observe blood flow or plantar temperature changes, and cannot serve as a daily therapy device. Twice during my internship in India during summer 2016, I traveled to CMC Vellore to visit Dr. Thomas and the hospital’s diabetic footwear fabrication lab to show them my preliminary idea for a wearable solution. These visits provided me a better understanding of the project’s constraints; I saw firsthand that if a patient cannot afford custom diabetic footwear, a hole is cut out from the sole of the patient’s shoe as a measure of last resort to offload the ulcer.

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The Healthcare Federation of India’s 2016 assessment of the Indian Healthcare industry suggested that 75% of medical devices in India are imported. While on average a U.S. patient will spend $400 annually on medical devices, an Indian will spend only $5. Dr. Chaturvedi, named one of 35 innovators under the age of 35 by MIT Technology review 2016 and inventor of 18 medical devices designed for the Indian medical market, questions how greatly the success of India’s healthcare system is stifled by the mismatch in medical technology need versus cost. After reading his book “Inventing Medical Devices in India,” and personally Skyping with him, I question how often we design solutions with only the first-world consumer in mind. My proposed project would foster an understanding between India and the U.S., emphasizing the responsibility of designing economically and culturally cognizant medical devices.

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Available in Canada for $2,500 is the SurroSense Rx, an in-shoe gait analysis tool for diabetic patients which identifies areas of increased, repetitive pressure as being at risk for ulceration. The SurroSense app helps patients modify their gait and tracks progress as the ulcered region is naturally off-loaded. However, three of four diabetics reside in low-income countries and the cost of SurroSense does not make it competitive in those medical device markets. Diabetes is known as “the disease of the poor” in India; I witnessed patients hesitant to purchase therapy footwear for 400 rupees (about $6). While SurroSense technology solves the need for a therapy device, a low-cost version is the only viable option for the majority of diabetics.

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While interning at the Indian Institute of Science - Bangalore, I began prototyping such a device, nicknamed the SmartShoe, and brought it to Dr. Thomas for discussion. The preliminary prototype uses pressure sensors integrated into the shoe to give feedback using auditory stimuli and low-cost LEDs concerning high-risk areas of pressure. I plan to continue the work I started on the SmartShoe by moving from the academic setting to work at the CMC Vellore Hospital with clinician Dr. Nihal Thomas in the endocrinology department, and Dr. Devasahayam in Bioengineering. The first step of this project is to continue developing the instrumentation to study the physiological progression of pressure, temperature, and blood flow during neuropathy. Once completed, the prototyped device has three intended applications: research, preventative diagnosis, and therapeutic footwear. The research stage will use the device to study the changes in plantar pressure distribution, temperature, and blood flow in three groups: healthy non-diabetics, diabetics without ulcer formation, and diabetics who have neuropathy and are at risk or already developing ulcers. The data collected during research will allow clinicians to begin to use the SmartShoe as a diagnostic device to predict patient neuropathy development based on trends in plantar temperature, pressure, and blood flow changes in order to prescribe preventative care. The SmartShoe can then develop into a therapy device as auditory and visual feedback would guide the patient in modifying their gait to stop and reverse the progression of ulceration. The current prototype is an insertable shoe sole that allows for custom placement of multiple integrated sensors based on a patient’s risk areas. Further SmartShoe development in gate modification will include delivering vibration feedback to a region on the patient’s leg unaffected by neuropathy which would allow the brain’s neuroplasticity to potentially re-establish the protective biofeedback lost to neuropathy.

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Beyond the immediate confines of my project, I am committed to learning the local Tamil language to connect more personally with the patients and to help them feel comfortable interacting with a new device. In addition, I am an avid ultimate frisbee player on my campus and joined the IISc-Bangalore team during my summer in India. I am enthusiastic about finding a frisbee community in Vellore or otherwise initiating a team on campus.

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Further development of the SmartShoe technology already has support from both the CMC Vellore hospital and bioengineering department as an inexpensive and portable device. Equipped with an electrical and biomedical engineering background, previous experience working in the Indian engineering environment, and multiple medical device prototyping experiences, I am confident in pursuing this research. Altogether, the overwhelming public health need for this device, combined with my compelling passion for designing culturally cognizant low-cost medical devices, creates a purpose I am fully driven and humbled to pursue.