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Source: http://www.doksinet A Comparative Pilot Study on Diabetic Foot Ulcers leading to Amputations Romisa Rehman- Final Year MBBS, Peshawar Medical College, Warsak road, Peshawar. Riphah University, Islamabad, Pakistan. Dr. Farhat Rehana Malik (MBBS, MPH) Associate Professor, Community Health SciencesPeshawar Medical College- Warsak Road, Peshawar Riphah University, Islamabad Pakistan Zarlish Rehman, (Fourth Year MBBS) Khyber Medical College, Peshawar University, Peshawar, Pakistan Correspondence Author: Dr. Farhat Rehana Malik, MBBS, MPH Associate Professor, Community Health Sciences, Peshawar Medical College, Warsak roadPeshawar. Riphah International University, Islamabad Pakistan E-mail: drfarhatmalik@gmail.com Cell: 03339061451 Contributors: RR conceived, designed, FRM did statistical analysis & editing of manuscript FRM did review and final approval of manuscript RR & ZR did data collection. No funding or any type of support was provided for this study. 1 Source:

http://www.doksinet ABSTRACT Objectives: To determine and compare the frequency of foot ulcers leading to amputations in relation to gender, type and duration of diabetes. Methodology; A descriptive study conducted at three teaching hospitals of Peshawar, from November- 2015 to February- 2016. Ethical considerations were duly taken care of Primary data was collected using convenient sampling technique via semi structured questionnaire. Inclusion criteria was set as diabetic, non- smoker, having no visible deformity other than ulcer or amputation, while patients critically ill, children less than 13 years, gestational diabetics and who did not consent upon were excluded. One hundred and twelve diabetics (Type- 1 & Type- 2) were included in the study. Data collected was entered and analyzed in SPSS- version 23 P- values computed by setting significance level at 0.05 Results; The patients included in the study were 112 in total. Mean age was 5355 with Standard deviation as 11.58

Among the study population 24 males (60%) had foot ulcers with 16 males (40%) got their lower leg amputated, whereas 55.5% females had foot ulcers with 24 (33%) amputations. Type- 1 diabetics with foot ulcers were 72% (n=44) while in type- 2 were 47% (n= 68). Diabetic foot ulcers were found to be highly significant with type of diabetes (p value= 0.007) Duration of illness more than 11 years was found to be risk factor for 90% amputations 2 Source: http://www.doksinet Conclusion; Diabetic foot ulcers were reported more in males and were found to be highly significant with type- 1 diabetes. Key Words; Foot ulceration, Neuropathy, Diabetes Mellitus, Type- 2 3 Source: http://www.doksinet Introduction; An important and common global metabolic disorders i. e Diabetes Mellitus affects about 2–5% of Europian populations and 20% in other parts of the world 1. New cases of diabetes mellitus are increasing worldwide; and it will get doubled with 366 million by 2030. Changing habits of

diet and longer life expectancy is the main reason behind it 2. Diabetes mellitus (DM) is a global non communicable disease with children, adolescents, and adults as the affected groups. Approximately 180 million people (95%) worldwide with type 2 DM (formerly called adult-onset diabetes) are reported by the World Health Organization 3. Deaths in relation to diabetesassociated complications accounted approximately 6% of global mortality 4 in the year 2000 Pakistan with high prevalence of diabetes ranks seventh thereby making diabetes as an epidemic 5, 6, 7&8. In a developing country like Pakistan, there are higher rates of diabetes and it’s complications as well as glucose intolerance causing a major social and economic burden. Although diabetic patients have a 15-fold higher risk of amputations but still half of these amputations could be prevented with early treatment, awareness and education among the patients regarding foot care and emphasis to have good glycemic control 7.

Diabetic foot ulcers (DFU) results due to loss of sensations, smaller blood vessels angiopathies, stress related to musculoskeletal disorders and uncontrolled blood glucose levels 9. Most of the patients with DFUs are admitted in health care centers, infection and ultimately amputations are the result of this morbidity. Amputation rates are higher in infected foot ulcers than to non-infected ulcers Diabetes is the sole cause of 50% non-traumatic amputations 10. 4 Source: http://www.doksinet Late referrals, inadequate medical facilities, and lack of awareness regarding foot care lead to ulcers. Amputations are preceded by foot ulceration among diabetics; hence it is extremely necessary to identify the persons at risk. Prevalence of diabetic foot ulceration is between 4 and 10% in Pakistan ulceration are 8–21% 11 as supported by researches, and the amputation rates following foot 12 & 13 . Early referrals, immediate management and awareness of taking care of one’s feet

can prevent amputation of the limbs with diabetic neuropathy and infections being the leading causes of gangrene in the developing world 14. Prevalence of 7.6 per cent and Pakistan will be the fourth country with highest diabetic population globally (13.8 million) 15 by the year 2030, as showed by National Institute of Diabetes and Endocrinology. Diabetes mellitus is the major cause of morbidities and mortalities. Prospective and descriptive studies consistently points to the fact that diabetic patients are more likely to develop complications which may be micro- as well as macro vascular 16 & 17. Rationale behind doing this type of study was the growing epidemic of diabetes in Pakistan, affecting every age and gender withrising cases every year here and non availability of reliable data. We intended to conduct this pilot study in our population to highlight the importance of this complication in diabetics. Frequency determination and comparison of foot ulcers leading to

amputations in relation to gender, duration and type of diabetes were the primary objectives of this study. 5 Source: http://www.doksinet Methodology; A hospital based study conducted in district Peshawar among three main Tertiary Care health facilities of Peshawar (Hayatabad Medical Complex, Khyber and Kuwait teaching hospital). Diagnosed admitted patients of type- 1 and 2 diabetes mellitus were the target population for the study. This study was conducted after ethical clearance and prior permission (MS and head of departments) from November- 2015 to February- 2016. One hundred and twelve patientsof 20- 78 years of age, were approached in the respective wards through non- probability sampling technique. Diabetics who were non-smokers with no visible foot deformity (other than amputation/ulcers due to diabetic complication) and new cases of diabetes also included in the study.American Diabetes Association 22, 28criteria was followed in relation to the duration of disease.No upper

age limit was chosen as patients can present with diabetic complications in their extreme ages. Critically ill patients, children of less than 13 years with type- 1 diabetes, gestational diabetes and the ones who did not consent upon were excluded. Informed verbal consent was taken from each patient During this study ethical considerations were duly taken care of. Data entered and analyzed in SPSS- version 23 with computation of percentages and p- values. Significance level was set at 0.05 6 Source: http://www.doksinet Results; A total 112 patients were enrolled in this study. Participant’s age ranged between 20- 78 years with minimum age as 23 years while maximum age limit was 78 years. Mean age was 5355 with Standard deviation as 11.58 Female dominance was seen among the admitted patients (males= 40, females= 72). This study was conducted from November- 2015 to February- 2016 The frequency of foot ulcers were prevalent in males as 60% (24 among 40), despite female dominance

among admitted patients of diabetes in the wards. On the other hand 555% (40 out of 72) females had ulcers. Among the males 16 (40%) had foot ulcers with lower leg amputation as compared to females amputations which were 24 out of 70 (33%).Thirty two individuals had associated visual disturbances, 40 had nephropathy, while 36 with cardiovascular problems. Patients when asked about the symptoms 64 people described burning or shooting sort of pain, with electrical or sharp sensations. 88 individuals felt tingling sensations, while 72 felt numbness. 28 individuals had claudication and 32 had cold feet 16 individuals complained of rest pain. Most of the patients had peripheral neuropathic symptoms On inspection, 70 patients had paleness, 60 had dry legs, 12 had hairless, 60 had some sort of infection, in which some patients had fungal other had bacterial infection, 60 had infection, 64 had new ulcers, 32 had muscle wasting. 7 Source: http://www.doksinet Table- 1; Gender wise Comparison

of amputations with P- Values Male Amputation Yes No Total Gender Female Total 16 24 40 24 48 72 40 72 112 Chi- Square Test P- Value 0.482 (Note; Gender wise distribution of foot ulcers leading to amputations P- value of 0.482 depicting non- significance) 8 Source: http://www.doksinet Comparison of foot ulcers leading to amputations in relation to gender are shown in Table- 1 along with the p- values. Foot ulcers in relation to type of disease along with their p- values are shown in Table- 2. The diabetic foot ulcers were found to be highly significant with type of diabetes (p value= 0.007) Duration of >11 years found to be a risk factor for 36 amputations out of 44 in type- 1 diabetes and 56 amputation in type- 2 diabetes, though not significant (p value= 0.085), details shown in Table- 3 Random blood sugar showed that 12 individuals had blood sugar level of 151-200mg/dl, 12 individuals had level between 201-250mg/dl, 60 individuals had level between

251-300mg/dl, while 28 had more than 301mg/dl. Glycemic control is related to the complications in diabetes Only 20 patients had good control on their disease and rest of the patients (n= 44) had poor glycemic control, whereas 48 had never checked their glycemic levels. 9 Source: http://www.doksinet Table- 2; Foot ulcers in relation to type of diabetes with the p- values Complications Foot ulcers TYPE- 1 Diabetes Mellitus TYPE- 2 Diabetes Mellitus (n=44) (n=68) 32 (72%) 32 (47%) Chi Square Test p- value 0.007 10 Source: http://www.doksinet Table- 3; Comparison of amputations with duration & type of disease Type of Diabetes Duration of disease <6years Type 1 Type 2 4 4 Total Chi- Square Test P- Value 8 0.085 Total 6-11 years 4 8 12 >11 years 36 56 92 44 68 112 (Note; Type- 1 & 2 diabetes amputations P value= 0.085, depicting not significant) 11 Source: http://www.doksinet Discussion; Diabetes Mellitus is a metabolic disorder and

a global epidemic with no exception to Pakistani population. Pakistan being a developing country bears the high burden of this non communicable disease, with an increased risk of contracting this disease among the inhabitants 18 . Diabetes substantially raises the morbidity and mortality in relation to this disease and quality of life is compromised among the sufferes18, 19. An important aspect of this study was to compare frequency of foot ulcers in relation to gender, duration of disease and type of the disease that was found to be highly significant by applying Pearson’s Chi square Test. It further showed male dominance among victims of diabetic foot ulcers though females were greater in number. Length of the disease had a direct effect on the development of foot ulcers but not found to be significant according to the results of this study. However maximum patients having HB1AC of more than 11% had amputations but this was not part of the objectives at present. Risk of micro

vascular and macro vascular complications in relation to raised HBA1c levels (>6.5%) and poor glycemic control were depicted in a landmark study of United Kingdom Prospective Diabetes Study (UKPDS) 18 . Type-2 diabetes with poor glycemic control has profound implications on health and is a major contributing risk factor for the development of diabetic complications 21. In an another research it was found that HbA1c levels of higher than 10% are associated with high risk of foot and diabetic foot deformities and reflects a poor glycemic control 20. Results of the present study revealed that complications like diabetic foot 12 Source: http://www.doksinet ulcers occurs with worse and poor glycemic controls like reported in other studies as well 23, 24 , however we did not take into account retinopathies in our study population. A study reported diabetic foot ulcers prevalence as 41.6% and 53% had past foot ulcers with peripheral neuropathies and peripheral vascular disease with

type- 2 diabetes mellitus along with epidemiological associates after adjusting their ages and duration of disease 25 , which is consistent with our results however frequency of past ulcers was not included in this study. The present study described neuropathic origin symptoms, which is consistent with the findings of a Pakistani study 26. DM in patients had a mead duration of 1722 months (143 years) in a study whereas present study showed this duration far less and we calculated duration of 11 years and more as risk factor for foot ulcers not consistent with this study. Male dominance in foot ulcers was also reported by them as in this study 27. On the other hand, the finding of the current study is higher when compared to a study conducted in Kenya in which results showed the burden of foot ulcers as 4.6 % in diabetic patients 29. More studies conducted in Addis Ababa, Ethiopia, and Nigeria found diabetic food ulcer prevalence to be 31.1% and 411%, respectively30, 31 Type of

diabetes mellitus was one of the strongest predictorsof diabetic foot ulcer occurrence. Those diabetic patientswho had type I diabetes mellitus were two times more likelyto develop diabetic foot ulcer than those who had type II DM depicting highly significant p- value as 0.007 This finding is inconsistentwith the studies conducted in Nigeria, Egypt, and Asia 2, 31, 32 which indicated type II diabetes mellitus significantly associated with the occurrence of diabetic foot ulcer. 13 Source: http://www.doksinet Small sample size, hospital based data and absence of control group were the main limitations of this study, so as a result cannot be extrapolated to rest of the district, city or the province. 14 Source: http://www.doksinet Conclusions/ Recommendations: The prevalence of diabetic foot ulcers among diabetic patients at Tertiary Care Hospitals of Peshawar was found to be high among males. Foot ulcers and relation to type of diabetes was highly significant according to the

results of this study. Recommendations following our study were as follows: • All the patients with diabetes should have HbA1c levels checked. • Patients with diabetes should be screened for foot complications regularly. • Early referral of diabetic patients from primary health care facilities to be screened early by a team of specialists. • Patients should be told to wear comfortable shoes. • As hygiene plays an important role, patients must be advised to take utmost care of it. 15 Source: http://www.doksinet References; 1. A S Fard, M Esmaelzadeh, and B Larijani, “Assessment and treatment of diabetic foot ulcer,” International Journal of Clinical Practice 2007; 61: 1931– 1938. 2. N Saad, K Elhadedy, N Ramadan, O Mohmady, and M Farid, “The prevalence and risk categorization of diabetic foot complications in cohort group in, Beni Suif, Egypt,” Life Science Journal 2013; 3: 10. 3. World Health Organization Diabetes: key facts [Online] Available at:

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