Treatment Outcome of Diabetic Foot Based on the Control of Random Blood Glucose and HbA1c in BIRDEM General Hospital, Dhaka, Bangladesh

Background: Diabetic foot is a common and potentially disastrous complication that can rapidly progress to irreversible septic gangrene, necessitating foot amputation. Objectives: To assess the clinical outcome of treatment of diabetic foot in diabetic patients based on random blood glucose (RBG) and HbA1c level. Materials and method: This prospective observational study was conducted in the Department of Surgery, BIRDEM General Hospital, Shahbag, Dhaka, Bangladesh, from July 2018 to December 2018. A total of 350 patients with diabetic foot were enrolled in the study based on inclusion and exclusion criteria. The patients were divided into four groups based on RBS and HbA1c level. A complete history was taken, thorough clinical examination was done and relevant investigation reports were collected. Collected data were classified, edited, coded, and entered into the computer for statistical analysis using SPSS version 23. Results: Mean age was 47.6±13.3 years in group A, 48.2±12.7 years in group B, 46.7±13.1 years in group C, and 49.9±12.5 years in group D. Male to female ratio was 2.3:1 in group A, 3.5:1 in group B, 1.5:1 in group C and 2.9:1 in group D. One hundred eight patients were found to have Wagner ulcer grading I. Among them, 2(20.0%) were in group A, 9(33.3%) were in group B, 12(36.4%) were in group C, and 85(30.4%) were in group D. Twenty-two patients were found to have Wagner ulcer grading IV. Among them, 1(3.0%) of group C and 21(7.5%) of group D. The difference was statistically significant (p<0.05) among the four groups. Two hundred eighty-eight patients had wound healing time of 2-6 weeks. Among them were 1(10.0%) in group A, 25(92.6%) in group B, 29(87.9%) in group C, and 233(83.2%) in group D. The mean wound healing time was found to be 1.5±0.7 weeks in group A, 3.1±1.3 weeks in group B, 3.6±1.2 weeks in group C and 4.9±1.8 weeks in group D. The difference was statistically significant (p<0.05) among four groups. One hundred six patients underwent amputation at a different level. Among them, 1(10.0%) in group A, 5(18.5%) in group B, 13(39.4%) in group C and 87(31.1%) in group D. The difference were not statistically significant (p>0.05) among four groups. Conclusion: Elevated HbA1c was associated with slower and incomplete foot healing in diabetic patients. Random blood glucose and HbA1c parameters can be used as dependable predictors of foot ulcer healing in the diabetic patients.


Introduction
Diabetes is a significant cause of morbidity and mortality, costing an estimated $245 billion in 2012 in the United States due to increased use of health resources and lost productivity. 1 Asia and the eastern Pacific region were particularly affected in 2011; China was home to the most significant number of adults with diabetes (i.e., 90.0 million, or 9% of the population), followed by India (61.3 million, or 8% of the population) and Bangladesh (8.4 million, or 10% of the population). 2,3In Bangladesh, the diabetic population was about 7.1 million in 2015, which is likely to increase to 13.6 million by 2040. 4 Apart from glycemic status, other local and general factors may influence the wound healing process (e.g., anemia, albumin, ischemia).The wound healing process relies heavily on oxygenation.In essence, low oxygen levels caused by anemia can halt or slow the wound healing stages.Almost 25% of people with diabetes will develop a diabetic foot at some time during their life, and 85% of major leg amputations begin with a foot.In the course of management of diabetic foot, blood sugar control and HbA1C have a tremendous impact on the treatment outcome.The healing rate, rate of infection, amputation rate, hospital stay, re-admission rate, diabetic complications, etc. are significantly higher in cases of patients with poor control. 5The optimal and desirable random blood glucose level should be <8.0 mmol/L in foot cases, reflected in different recent clinical studies.HbA1c is another essential clinical parameter to predict the outcome, which was neglected in the previous years.HbA1c level < 7% is associated with better results in surgical practice.It is estimated that approximately 15-25% of diabetic patients develop diabetic foot during the course of the disease, which is associated with worse out comes, especially when it is related to poor glycaemic control (random blood glucose >10 mmol/L).People with diabetes can progress into chronic ulcers, often leading to amputation if not treated promptly.Advanced age, male gender, and neglected glycaemic control are the prime factors associated with amputation. 6Most often, the incidence of infection has a positive association with poor blood sugar control, predominantly random blood glucose.Some studies also suggest that glycaemic control is also a major contributing factor to the development of superseded infection on a diabetic foot. 7Over this less emphasized issue, there is no satisfactory clinical trial yet in our country, nor is there sufficient, authentic, and evidence-based data regarding the management of diabetic foot based on the control of random blood glucose and HbA1c in our clinical context.From that point of view, this research study is designed to find out different dimensions of clinical outcome of diabetic foot in relation to the control of blood sugar.

Results
A total of 350 patients were included in the study based on inclusion and exclusion criteria.Based on the control of random blood sugar (RBS) and HbA1c before the initiation of treatment, the total study population was divided into four groups.
The mean age was found to be 47.6±13.

Discussion
Diabetic foot is a devastating complication of diabetes mellitus because it is primarily associated with amputation and the resulting disability of individuals. 8It is estimated that 70% of nontraumatic amputations performed in First World hospitals are due to diabetic foot. 9urthermore, it is estimated that 15% of people with diabetes develop throughout their life a foot lesion, 10   lower limb amputations. 11Most diabetic foot trials focus more on therapeutic or diagnostic aspects than on prevention.However, the impact of these processes on patients, in terms of their quality of life and disruption of their psychosocial environment, has been studied to a lesser extent.
The In our study, the male-to-female ratio was 2.3:1 in group A, 3.5:1 in group B, 1.5:1 in group C, and 2.9:1 in group D. The difference was not statistically significant (p>0.05)among four groups.Porselvi et al. 12 found that out of 86 patients, men were around 68.6%, and 31.4% were women.Rehman et al. 13 showed that there were more females among the admitted patients as compared to males (72 vs. 40 respectively).The male to female ratio was 1:1.8.Manjunath and Kumar 9 observed in their study where 280 patients (male n = 196, 70%; female n = 84, 30%) were enrolled in the study.Muduli et al. 14 documented that among the 60 diabetic foot ulcer patients studied, 42(70%) were males, and 18(30%) were females.The male-to-female ratio was 2.33:1.
In  16 showed similar observations with HbA1c as a predictor of the foot ulcer healing process.Forty-eight percent of diabetic patients with controlled HbA1c (<7 mmol/L) had foot ulcer healing within 3 months, 44% had healed in 3-6 months, and 8% took >7 months for complete healing of the foot ulcers.On the other hand, in patients with uncontrolled diabetes indicated by highly elevated HbA1c (>7 mmol/L), a significant delay in foot ulcers was observed in the majority of the patients.Comparing patients with controlled high HbA1c, only 23% of patients had healed foot ulcers within 3 months, 28% between 3 and 6 months, and 48% at 7 months (P=0.024).
Given that glycated hemoglobin HbA1c is a reliable marker of glycemic control spanning over the previous 2-3 months, 17 it is now being recommended by the American Diabetes Association and World Health Organization as a reliable marker for diagnosis of diabetes.
Manjunath and Kumar 9 observed that 50% of diabetic patients with controlled HbA1c (7 mmol/L) had foot ulcer healing within 3 months, 40% had healed in 3-6 months, and 10% took 7 months for complete healing of the foot ulcers.On the other hand, in patients with uncontrolled diabetes indicated by elevated HbA1c (>7 mmol/L), a significant delay in foot ulcers was observed in the majority of the patients.
performed amputation only when there was a gangrenous toe (minor amputation) or foot (major amputation).Major amputation (below knee or above knee) was performed in 5.5% (n = 8) and minor amputation (toe or transmetatarsal) in 22.6% (n = 33).Parisi et al. 22 showed in their study that minor amputation was performed in 82.7% and major amputation in 17.3%.
Several limitations exist in the present study: short time, small sample size, and randomization were not done.Therefore, selection bias in this study cannot be eliminated.

Conclusion
Diabetes foot disease (DFD) causes deterioration in the quality of life and affects the quality of care for diabetic patients.Elevated HbA1c was associated with slower and incomplete foot healing in diabetic patients.Given their reliability as tools to diagnose and monitor diabetes and its related complications, random blood glucose and HbA1c parameter can be used as dependable predictors of foot ulcer healing in the diabetic.Effective glycemic control, optimal wound care, aggressive medical management, and timely surgical intervention may decrease disabling morbidity with a better outcome.This all needs to develop in a multidisciplinary team in all medical institutions for better care of the diabetic foot.
Patients with diabetes should be screened for foot complications regularly.Early referral of diabetic patients from primary health care centers to the tertiary health care / diabetic center is of paramount importance to be screened early for the diabetic complications by the multidisciplinary specialist team.Further studies can be undertaken by including a large number of patients.