Correlation of Hemoglobin A1c With Wagner Classification in Patients With Diabetic Foot

Introduction Diabetic foot is a common complication of diabetes mellitus (DM). The Wagner classification is mostly used to grade its severity. The correlation between the hemoglobin A1c (HbA1c) and the Wagner classification is still controversial. Therefore, the purpose of this study is to determine the correlation of HbA1c with Wagner classification in patients with diabetic foot. Materials and methods This cross-sectional study was conducted at a major hospital in Shaheed Benazirabad in which 88 patients aged 18-65 years, of either gender, with a known history of DM type I or type II, and diagnosed with diabetic foot were enrolled for six months. Blood samples were collected to check the HbA1c levels. Wagner classification grading was performed after the examination of diabetic foot ulcers. Demographics such as age, gender, duration of DM, and other risk factors of foot ulcers were also noted. The mean and standard deviation for continuous variables, such as age and HbA1c level, and the frequency and percentage for categorical variables, such as distribution of age, distribution of HbA1c, gender, duration of DM, grades of Wagner classification, and other risk factors of foot ulcers, were calculated. The correlation of HbA1c with Wagner classification was also calculated by applying the chi-square test and taking p ≤ 0.05 as significant. Results The mean age of the study population was 47.4 ± 10.6 years. Of the 88 patients, 15 (17.04%) were 25-35 years of age, 34 (38.63%) were 36-50 years of age, and 39 (44.31%) were 51-65 years of age; 45 (51.13%) patients were males and 43 (48.86%) patients were females. The mean HbA1c level of the study population was 9.07 ± 1.65%; 5 (5.68%) patients had 6.5-7.5%, 34 (38.63%) patients had 7.6-8.5%, 24 (27.27%) patients had 8.6-9.5%, and 25 (28.41%) patients had an HbA1c level of >9.5%. Twelve (13.63%) patients had ≤ 7 years, 18 (20.45%) had 8-15 years, and 58 (65.9%) had >15 years of duration of DM. Zero (0%) patients had grade 0, 1 (1.13%) patient had grade 1, 6 (6.81%) patients had grade 2, 29 (32.95%) patients had grade 3, 32 (36.36%) patients had grade 4, and 20 (22.72%) patients had grade 5 of Wagner classification. 23 (26.13%) patients had foot abnormalities, 19 (21.59%) patients had nephropathy, 13 (14.77%) patients had neuropathy, 14 (15.91%) patients had hypertension, 9 (10.22%) patients had retinopathy, 3 (3.41%) patients had foot ulcers/toe amputation, 2 (2.27%) patients had a cognitive deficit, and 5 (5.68%) patients had cardiovascular diseases. The correlation of HbA1c with Wagner classification was found statistically significant with p < 0.00001. Conclusions The older age, male gender, longer duration of DM, increased HbA1c, and previously existing foot abnormalities in diabetic patients are the risk factors of diabetic foot. The monitoring of HbA1c can help predict the diabetic foot in the aforesaid high-risk diabetics because the HbA1c linearly rises with the higher grades of Wagner classification of diabetic foot. Subsequently, the strict control of HbA1c as well as patient education about proper foot care can help prevent diabetic foot and its complications. However, more studies on larger scales are needed to establish the factual relationship between HbA1c and Wagner classification.


Introduction
The diabetic foot has a prevalence of 4% to 10%, with an annual incidence of 1% to 4.1% in patients with diabetes mellitus (DM). All ethnic groups have a 25% lifetime prevalence of diabetic foot [1].
The most frequently used classification system for the diabetic foot that evaluates ulcer depth and bone involvement is the Wagner classification, which aids in the execution of a proper treatment plan and estimation of the possible outcomes. The other, not usually applied, classification systems assess ischemia, neuropathy, and the degree of infection [2,3].
The frequency of diabetic foot ulcers in different regions of the foot and the grades of Wagner classification has already been defined. Aamir et al. stated that diabetic foot ulcers were at the forefoot in 59%, midfoot in 25%, and hindfoot in 16% of patients [4]. Hasan et al. determined the frequency of grades of Wagner classification and showed that 5.5% of patients had grade 1, 30% had grade 2, 20% had grade 3, 33.3% had grade 4, and 11.1% had grade 5 ulcers [5]. Ashraf et al. stated that 74% of patients had grade 2 and grade 3 ulcers, whereas 24% of patients had grade 5 ulcers. They also found that 75% of patients were cured with limb salvage, whereas 25% could not recover without limb amputation. They also established that 22.6% to 47% of these ulcers were neuropathic, 59% were neuro-ischemic, and 18.3% were ischemic in nature [6].
The current literature is debatable about the correlation between hemoglobin A1c (HbA1c) levels and the Wagner classification. Therefore, our study is aimed at determining the correlation of HbA1c with different grades of Wagner classification in patients with diabetic foot.

Study design and sampling
This cross-sectional study was conducted at Peoples Medical College Hospital, Shaheed Benazirabad, from October 10, 2019, to April 10, 2020 (for six months). Non-probability consecutive sampling technique was used. Through Raosoft sample size calculator, the sample size came out to be 88 patients by taking a confidence interval of 95% and a prevalence of 25%, and keeping the margin of error at 9%. Inclusion criteria are age 18-65 years, either gender, a previously diagnosed DM type I or type II, and a diagnosed diabetic foot ulcers. Young patients who had insulin-dependent diabetes were classified as having type I DM, and middle-to oldaged patients who were on oral hypoglycemic drugs were classified as having type II DM. Exclusion criteria excluded patients having liver malignancy, end-stage renal disease, coexisting viral infection (such as hepatitis B), pregnancy, traumatic ulcers, vascular disorders, Buerger's disease, and peripheral vascular disease, or using interferon therapy.

Data collection
Patients presenting to the outpatient department or admitted to the hospital and meeting the inclusion/exclusion criteria were enrolled in this study. The pros and cons of the study were explained, and informed consent was obtained. A blood sample was collected and sent to the institutional laboratory for the HbA1c level analysis. Grading of the diabetic foot was performed after examination of the wound using Wagner classification, as shown in

Data analysis
Data were entered and analyzed using SPSS Version 20 (IBM Corp., Armonk, NY, USA). Mean and the standard deviation were calculated for age and HbA1c level. Frequency and percentage for range of age, range of HbA1c, gender, duration of DM, grades of Wagner classification, and other risk factors of foot ulcers (foot abnormalities, nephropathy, neuropathy, hypertension, retinopathy, foot ulcers/toe amputation, cognitive deficit, and cardiovascular diseases) were also calculated. Correlation of HbA1c with Wagner classification was also calculated, the chisquare test was applied, and p ≤ 0.05 was considered as significant.

Results
The mean age of the patients was 47.4 ± 10.6 years, as shown in Table 2.

FIGURE 2: Gender distribution
The mean HbA1c level of the patients was 9.07 ± 1.65%, as shown in Table 3.

FIGURE 3: HbA1c distribution
HbA1c, hemoglobin A1c The duration of DM was ≤7 years in 12 (    Correlation of HbA1c with Wagner classification showed a statistically significant linear relationship with p < 0.00001. Mostly, patients with grade 4 and 5 were found to have HbA1c > 8.5%. However, patients with grades 1-3 also had HbA1c > 6.5%. These findings are shown in Table 4.

Discussion
This study indicates that there is a linear relationship between the HbA1c level and the grades of Wagner classification. Patients classified in grades 0-2 of Wagner classification had slightly elevated HbA1c levels, whereas patients with grades 3-5 had the highest HbA1c levels mainly due to non-compliance of the patients.
Diabetic foot syndrome includes several diabetic foot pathologies such as infection, neuropathic osteoarthropathy, and diabetic foot ulcers. Diabetic foot, which is about 15% of these and is projected to grow up to 25%, is the most hazardous condition, which may lead to limb amputation [8].
Diabetic foot is caused by minor injuries that are not perceived for a long time by diabetic patients due to peripheral nerve dysfunction. Furthermore, peripheral nerve dysfunction often gets associated with peripheral arterial disease leading to the deficient blood supply to the limbs, a condition known as diabetic angiopathy, which may also cause diabetic foot. Therefore, the diabetic foot can be neuropathic, neuro-ischemic, or ischemic alone [6,9,10].  [14].
The precautionary measures that patients should be educated about to decrease the incidence