Risk Factors and Surgical Outcomes of Diabetic Foot in Diabetic Patients at King Fahad University Hospital

Background: Diabetes mellitus affects a large number of the population worldwide. One of the most important complications is diabetic foot ulcers, which are debilitating to the patient and the health care system. Objectives: To assess the risk factors leading to diabetic foot complications and the surgical outcome of management of patients affected by diabetic foot at King Fahd University Hospital. Methods: This is a retrospective case series study conducted at King Fahd University Hospital. The study included 52 patients who were admitted from the period 2007 to 2017 with cases of diabetic foot ulcers. The study includes a review of medical charts for diabetic foot patients including demographics, diabetic profile, associated comorbidities, clinical signs, laboratory investigations and surgical outcome. Results: Our study shows that diabetic foot patients had comorbidities like hypertension at 69.2% and hyperlipidemia at 55.8%. Regarding the association between comorbidities and surgical outcomes, we did not find any significance. Furthermore, we found that patients with gangrene were more likely to undergo amputation. Patients who underwent amputation had hemoglobin A1c (HbA1c) of 10.3 ± 2.4% and random blood sugar (RBS) of 259 ±107 mg/dl, indicating poor diabetic control. Conclusion: Diabetic foot is the result of poor blood sugar control. Surgical intervention plays an important role in the management of diabetic foot. Depending on the presentation, patients may undergo surgical debridement, revascularization, or amputation. We found that patients who developed gangrene were more likely to undergo amputation.


Introduction
Diabetic foot disease can be defined as infection, ulceration, or destruction of tissues of the foot of a person who is diagnosed with diabetes mellitus (DM) and which is usually associated with neuropathy and/or peripheral arterial disease in the lower extremity [1]. A usual presentation involves a trauma to the foot due to loss of sensation, along with poor healing and neglect. This may further develop into ulcers and gangrene depending on how early the presentation was. When medical management for diabetic foot is insufficient, advanced surgical management like amputation will be required [2]. Diabetic foot patients have higher mortality rate than patients without diabetic foot [3]. Moreover, a large number of diabetic foot patients will need surgical intervention, which will increase the rate and the duration of inpatient hospitalizations. The amputation rate is rising, which serves as a major concern that leads to the importance of implementing all precautions and safeguarding measures for foot care [4]. Therefore, this study aims to estimate the risk factors and the surgical outcomes of diabetic foot. Estimating the risk factors and surgical outcomes of diabetic foot can be assessed in the management process.

Materials And Methods
This is a retrospective observational study done at King Fahad University Hospital in Al Khobar, Saudi Arabia. The study included patients admitted from 2007 to 2017 as cases of diabetic foot which includes ulcer, gangrene, or vascular complications. Data collection was done through the hospital's information system (Quadramed) which contained the patients' medical files. All patients who did not meet the criteria were excluded from the study. Exclusion criteria include patients with incomplete records or patients who were admitted for other medical complaints, pediatric age group and traumatic patients . The total number   1  2  2  2   2  2  3  1 of diabetic foot patients admitted from the period 2007 to 2017 was 198 patients. The number of patients who met the inclusion criteria was 52 patients.
All-important data that can contribute to the risk of diabetic foot development were collected and analyzed including patient's identification data, associated comorbidities, details of the diabetic course of illness like type of diabetes, presence of previous ulcer, micro and macrovascular complications with their prevalence, and surgical outcome including use of debridement, revascularization, and amputations.
Data collection and analysis of laboratory reports were done for interpretation of diabetic course and severity including fasting blood sugar (FBS), hemoglobin A1c (HbA1c), random blood sugar (RBS), blood urea nitrogen (BUN), and lipid levels. Physical examinations for neuropathy, retinopathy, and peripheral vascular disease were collected. In addition, more local and specific exams were done for common conditions associated with diabetes like cellulitis callus, Charcot foot, and the presence of gangrene and ulcers. The outcome was determined based on thorough assessment including labs, imaging, and clinical assessment of limb viability to determine whether to save the limb by doing a revascularization therapy or amputation. Moreover, we included in our study a cross relation to see the association among the means of the lab results including HbA1c, RBS, BUN, total cholesterol (TC) and the surgical outcomes whether it is amputation, revascularization, or debridement. Those associations were analyzed to have a more detailed view on what affects the outcome of diabetic foot.
Data analysis was done by the IBM SPSS version 21 (IBM Corp., Armonk, NY, USA). Categorical values were described as frequency and percentage. Numerical variables were used to calculate the mean and the standard deviation. Chi square test was used for comparison of the observed and expected results. To interpret the significance of the results a p-value of less than 0.05 was considered significant.    Comorbidities found in the diabatic foot patients were as follows: hypertension (69.2%) and hyperlipidemia (55.8%) were found in more than half of the patients, followed by chronic kidney diseases (26.9%), coronary artery diseases (17.3%) and thyroid disease (1.9%).

Results
Diabetes complications included neuropathy (31; 59.6%), followed by nephropathy (22; 42.3%) and retinopathy (18; 34.6%). Nine (17.3%) of the patients were noted to have coronary heart disease. As evidenced by the results ( Table 2) on mean, patients presented with more than one diabetic complication alongside diabetic foot.
In the relation between debridement and retinopathy, a statistically significant p value was noted (0.05). Also, in the relation between debridement and coronary heart disease the same value was noted (0.05). Another statistically significant p value was shown in the relation between amputation and the presence of previous ulcers (0.02).

Discussion
The goal of this study was to evaluate the outcomes of diabetic foot in diabetic patients, categorizing them as amputation, revascularization, and debridement treatments. The study was also planned to investigate the influence of several risk variables on diabetic foot outcomes, including patients' gender, comorbidities, diabetic complications such as peripheral neuropathy, and prior ulcers.
Identifying variables that are linked to the development of diabetic foot is critical in clinical practice, to prevent its occurrence among high-risk diabetic patients. Hypertension is one of the powerful predictors and modifiable risk factors for the macrovascular and microvascular complications of diabetes. Previous research found that diabetic foot was linked to hypertension [5], which is consistent with our findings. Furthermore, hypertension prevalence is twice in diabetic individuals compared to non-diabetics [6]. In addition, in our results, more than half of diabetic patients with hypertension had an amputation, two patients had revascularization, and 16 patients had debridement. Arterial hypertension influences foot ulcer and gangrene development by increasing arterial wall stiffness and plaque formation in the lower extremities, which are the main reasons for the co-existence of hypertension and the aforementioned outcomes [5].
Other comorbidities like hyperlipidemia were found to be common among the group, at 29 patients. Moreover, 14 diabetic patients suffered from chronic kidney disease, and all of these comorbidities factors are related to a worse outcome [7].
A history of previous ulcers raises the chance of additional lesions and carries a risk of lower extremity amputation, which is equivalent to those who have had their first ulcer [8,9]. According to our study, recurrence of ulcers was found in 38% of patients, 14 patients of which had to be amputated, one had to be revascularized, and 11 had to be debrided. This discovery is critical because foot ulcers may be avoided with proper education on foot care and attention to footwear [10,11]. A strong link exists between amputation and ulcer recurrence according to our findings.
One of the key risk factors for all diabetic foot issues is peripheral neuropathy. All participants who did not have peripheral neuropathy had healed ulcers without sequelae according to our results. This substantial link between peripheral neuropathy and diabetic foot issues was also found in a study where 33% of diabetic patients had chronic nerve compression [12].
In our study, 17 patients had to be amputated, three had to be revascularized, and 15 had to be debrided.
Improving glycemic control, and patient education about foot care are critical steps in reducing the burden of diabetic foot and its impact on the quality of life.
Analysis and interpretation of lab results are an essential part of assessment of disease progression, severity and for establishing a diagnosis, especially for diabetic foot. HbA1c was high which necessitated reevaluation of the medical management, drug regimen and the need for inclusion of lifestyle modifications. Moreover, the RBS level was also high, and if not controlled it can lead to hyperglycemic hyperosmolar state and severe dehydration.
According to our findings, patients who did amputation, revascularization and debridement had a mean HbA1c of 10.3%, 10.7%, and 10.3% respectively. All HbA1c levels are very high above the 10% mark, which may indicate the relation between high HbA1C and surgical intervention in any form. In addition, we measured BUN levels to monitor the progression of kidney disease and to avoid any drug-related nephrotoxicity. Elevated BUN showed an involvement in the outcome; the highest recorded value was 24.3mg/dL which was associated with amputation. Also, it is crucial to monitor cholesterol levels specifically in diabetic patients, due to the increased risk of developing macrovascular complications that affect the heart and the peripheries and try to keep it at normal values [13]. Patients with higher total cholesterol levels are more vulnerable to macrovascular complications in the form of ulcers and gangrene [14].
Diabetic complications can show the progression of the disease and can be a factor in prognosis [15]. Nephropathy was common with 22 of the patients being affected. Multiple studies showed that patients with end-stage renal disease are at higher risk of complications like amputation, gangrene, and ulceration [16][17][18]. A study involving 430 patients found that the presence of retinopathy placed the patients at an increased risk of developing diabetic foot ulcers. We found around one-third of our patients had retinopathy as a diabetic complication, so those patients are at risk [19].
Other findings that can increase the risk of amputation are the presence of ulcers, which affected a very high number of the group (43), and gangrene which was present in 21 patients in examination [20]. A significant relation was established between both patients who had previous ulcers and patients who had gangrene upon examination with the need for amputation later on as an outcome, which was also shown in other studies. This would lead us to believe that prevention of both the development of gangrene and ulcers is of great importance [21].
In our view, we advise that primary health care practitioners promote their participation in diabetic foot screening by employing foot screening instruments, as well as patient education. The importance of early identification and care of diabetic foot cannot be ignored, because diabetic patients are at risk of diabetic foot complications, such as the elderly and those with poorly managed or long-term DM, bigger ulcers, and peripheral neuropathy, should be given extra attention. The patient's age, diabetes duration, glycemic control, ulcer size, and comorbidities such as peripheral neuropathy can all be used to predict the patient's diabetic foot result. Larger research is needed in the future to further assess diabetic foot consequences in Saudi Arabia.

Limitations and recommendations
The study is a retrospective with a small sample size, due to limited information about the duration of the disease and the oral hypoglycemic agents due to insufficient data in the system. There are many co-founding factors that might affect the surgical outcome; thus, we suggest a propensity-matched study to be performed prospectively to get more accurate results with a larger sample size.
organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.