• Study design & Settings

This cross sectional study would be conducted at Civil Hospital, Naraingarh, a secondary level rural hospital attached to Community Medicine Deptt. Of PGIMER, a tertiary care hospital of North India. The Non Communicable Disease clinic at the hospital run by faculty and resident doctors of Community Medicine receives patients from Naraingarh and nearby blocks of Ambala district, mainly rural in nature and caters to a population of about 100,000-150,000. The aim of the hospital is to provide good quality health care that is easily accessible, affordable, and culturally acceptable, and to serve as a model for training post-graduates in community medicine and family medicine. Average general out-patient department (OPD) attendance of the clinic, including new and revisits, is around 100 per day.

• Study population and Sample size

All diabetes cases as per WHO criteria (FBS≥126 mg% or PPBS≥200 mg %) diagnosed for at least six months of duration would constitute the study population. Those with cognitive impairment and obvious disability that could affect the functions of the nervous system affect independent self-care behavior, pregnant women and those who had undergone amputations of the lower limbs would be excluded from the study.

According to previous study done by George H [9], the prevalence of peripheral neuropathy among people with diabetes was reported to be 47%. Thus, at confidence interval of 95% and 80% power with 10% absolute precision on prevalence of 47%, sample size of 96 subjects is obtained. However, a total of 150 consecutive patients who are eligible and giving consent would be enrolled taking a design effect of 1.5 for cluster.

• Study tools

All the enrolled participants would be administered a semi-structured questionnaire developed by the investigators. The first part of the questionnaire would consist data on socio-demographic details, history of diabetes mellitus including treatment details and associated risk factors for development of diabetic foot including dietary habits, physical activity, tobacco use and alcohol consumption, anthropometric details(height, weight, waist circumference, BMI), associated co- morbidities such as hypertension and dyslipidemia and laboratory parameters to assess glycaemic control such as FBS and HBA1C levels. The second part of the questionnaire would assess peripheral neuropathy by Michigan Neuropathy Screening Instrument (MNSI) [10], a simple and validated screening tool for diabetic peripheral neuropathy (DPN). The MNSI is designed to be used in an outpatient setting by primary care providers. It has two components, the history and the physical assessment. The first part of the instrument comprises of 15 self-administered “yes or no” questions on foot sensation including pain, numbness, and temperature sensitivity. A higher score (out of a maximum of 13 points) indicates more neuropathic symptoms and score of 7 or higher would denote neuropathy. The second part of the MNSI is a brief physical examination involving 1) inspection of the feet for deformities, dry skin, hair or nail abnormalities, callous, or infection; 2) semi-quantitative assessment of vibration sensation at the dorsum of the great toe; 3) grading of ankle reflexes; and 4) monofilament testing. Patients screening positive on the clinical portion of the MNSI (greater than 2.5 points on a 10 point scale) would be considered neuropathic and would be considered as having high risk feet. The physical assessment would be performed by one of the investigators who is trained in using it. The participants found to be having foot problems would be classified according to The International Working Group on Diabetic Foot (IWGDF) Risk Classification System [11]. Health education regarding foot care practices would be given to all subjects. Subjects found to be in category 1 or 2 would be managed at the health facility by the investigators and participants with category 3 risk would be referred to department of endocrinology, PGIMER, Chandigarh.

• Statistical analysis

The data collected would be entered in excel sheets and would be tabulated and analyzed using software SPSS (Statistical Package for Social Sciences) V.18.0 for windows. The data would be cross checked for data entry errors. Findings would be described in terms of proportions and their 95% confidence intervals. Continuous data would be summarized using mean, and standard deviation or median and inter quartile range depending on skewness of data. Chi-square test would be used to find the association and p-value < 0.05 would be considered significant. Multiple logistic regression analysis would be performed to find out the independent risk factors for development of diabetic feet.

• Ethical considerations

The study would not involve any potential risks to the participants. The participants would be screened for peripheral neuropathy through a non-invasive screening instrument and the screening would help in its timely diagnosis so as to prevent patients from developing diabetic foot ulcers and amputation and would further help in improving their quality of life. The data of the participants would be kept confidential and the study would be sent for approval from IEC, PGIMER, Chandigarh.