European Journal of Cardiovascular Medicine

Diabetes mellitus has emerged as one of the most important public health challenges worldwide. The prevalence of diabetes has increased significantly over the past few decades due to rapid urbanization, sedentary lifestyle, dietary changes, and ageing populations. India currently has one of the largest populations of individuals with diabetes. In 2021, approximately 74–75 million adults aged 20–79 years were living with diabetes in India, and this number is projected to increase to nearly 125 million by 2045, indicating a rapidly growing disease burden (1). Recent national surveys estimate the prevalence of diabetes in India to be 7–9% among adults, with higher rates observed in urban populations (2). The increasing prevalence of diabetes has consequently resulted in a rise in chronic complications, among which diabetic foot disease represents one of the most serious causes of morbidity.

Diabetic foot ulcer (DFU) is a common and potentially severe complication of diabetes mellitus. It develops due to the combined effects of peripheral neuropathy, peripheral arterial disease, and minor trauma, which together impair protective sensation, tissue perfusion, and wound healing (3). It is estimated that nearly one in four individuals with diabetes will develop a foot ulcer during their lifetime, and the annual incidence of diabetic foot complications ranges between 1–2% among diabetic populations (4). Diabetic foot infections are a major cause of hospitalization and significantly impair quality of life due to reduced mobility and increased disability.

Lower limb amputation is one of the most serious consequences of diabetic foot disease. Approximately 80% of diabetes-related lower extremity amputations are preceded by diabetic foot ulcers (5). Amputation is associated with substantial physical, psychological, and economic burden for both patients and healthcare systems. Therefore, early identification of patients at high risk of limb loss is essential for effective management and improved clinical outcomes.

Traditional classification systems such as the Fontaine and Rutherford classifications primarily focus on the severity of ischemia in peripheral arterial disease. However, diabetic foot ulcers are multifactorial, and outcomes depend not only on perfusion status but also on wound characteristics and infection severity (6). To overcome these limitations, the Society for Vascular Surgery (SVS) introduced the Wound–Ischemia–Foot Infection (WIfI) classification system, which evaluates three major components: wound extent, degree of ischemia, and severity of infection. Each component is graded from 0 to 3, and the combined score determines the stage of limb threat and risk of amputation (7).

Recent studies have shown that the SVS-WIfI classification system has strong prognostic value in patients with diabetic foot ulcers, with higher stages associated with increased risk of amputation and poorer clinical outcomes (8,9). In view of the increasing burden of diabetic foot complications, the present study aims to evaluate the role of the SVS-WIfI scoring system in predicting amputation risk and to analyze the relationship between individual components of the WIfI score and outcomes among patients with diabetic foot ulcers.

Study Design and Duration This prospective observational study was conducted over a period of one year from January 2024 to January 2026. All enrolled patients were followed up for six months after recruitment to evaluate clinical outcomes. The study was approved by the Institutional Ethics Committee. All procedures were conducted in accordance with ethical standards for research involving human participants. Study Setting and Population The study was carried out in the Department of General Surgery. Patients presenting with diabetic foot ulcers were screened for eligibility. Eligible participants were informed about the objectives and procedures of the study and written informed consent was obtained before enrollment. Method of Selection All patients presenting with diabetic foot ulcers during the study period who met the eligibility criteria were included consecutively. Patients admitted under the Department of General Surgery were recruited for the study.   Inclusion Criteria 1. Patients aged 18–70 years. 2. Patients presenting with diabetic foot ulcers to the General Surgery OPD. 3. Patients who provided informed consent for participation. Exclusion Criteria 1. Patients who did not provide consent. 2. Pregnant women. 3. Patients with acute limb ischemia, traumatic wounds, non-atherosclerotic ulcers, or pure venous ulcers. Clinical Evaluation and Staging All recruited patients underwent detailed clinical evaluation using the Society for Vascular Surgery Wound–Ischemia–Foot Infection (SVS-WIfI) classification system. The wound component was assessed by examining the depth of the ulcer, tissue loss, and presence of gangrene. The ischemia component was evaluated using Ankle–Brachial Pressure Index (ABPI) and toe pressure measurements to assess limb perfusion. The foot infection component was assessed based on clinical signs of local inflammation such as erythema, warmth, tenderness, and purulent discharge, as well as systemic signs of infection. Based on these parameters, a WIfI score was calculated for each patient. Patients were categorized into stages according to the severity of limb threat. For analysis, patients were divided into two groups: • Group 1: WIfI stages 1–3 • Group 2: WIfI stage 4 A total of 70 patients were included in the study, of whom 20 patients belonged to Group 1 and 50 patients belonged to Group 2. Routine laboratory investigations relevant to diabetic foot evaluation were recorded for all patients. Follow-up All patients were followed up for six months from the time of recruitment. Follow-up was conducted through outpatient visits or telephone contact when patients failed to attend scheduled visits. Clinical records and outpatient charts were reviewed to determine patient outcomes. Outcome Measures The primary outcome was the occurrence of lower limb amputation within six months of recruitment. Amputations were classified as minor amputations (ray or transmetatarsal amputations) and major amputations (amputation above the trans-tarsal level). The secondary outcome was the association between individual components of the WIfI classification system (wound severity, ischemia, and infection) and the incidence of amputation. Statistical Analysis Data were entered into Microsoft Excel and analyzed using SPSS statistical methods. Categorical variables were expressed as frequency and percentage, and statistical significance was determined using the Chi-square test or Fisher’s exact test, with p < 0.05 considered statistically significant.

Table 1 shows the distribution of study participants according to study group, age, and gender. A total of 70 patients with diabetic foot ulcers were included in the study, of which 20 patients (28.6%) belonged to Group 1 (WIfI stages 1–3) and 50 patients (71.4%) belonged to Group 2 (WIfI stage 4). The overall mean age of the patients was 55.26 years, with the youngest patient being 29 years and the oldest 70 years. The mean age in Group 1 was 51.7 years, whereas in Group 2 it was slightly higher at 56.68 years, indicating that patients with more severe disease tended to be older.

Table 1. Distribution of Patients According to Study Group, Age, and Gender (n = 70)

With respect to gender distribution, male patients predominated in both groups. Overall, 46 patients (65.7%) were males and 24 patients (34.3%) were females. In Group 1, 75% of patients were males, while in Group 2 62% were males, demonstrating a higher prevalence of diabetic foot ulcers among male patients in this study population.

Figure 1. Distribution of Patients According to Study Groups

Figure 1 shows the distribution of patients according to the WIfI staging groups. Out of the 70 patients included in the study, 20 patients (28.6%) belonged to Group 1, which included patients with WIfI stages 1–3, representing relatively lower stages of limb threat. The remaining 50 patients (71.4%) belonged to Group 2, which included patients with WIfI stage 4, indicating a higher severity of disease and greater risk of amputation. This distribution suggests that a majority of patients in the present study presented with advanced diabetic foot disease, highlighting the importance of early evaluation and management.

Amputation was significantly more common in Group 2 patients (WIfI stage 4) compared to Group 1 patients (WIfI stages 1–3). In Group 1, only 35% of patients underwent amputation, whereas 84% of patients in Group 2 required amputation during the six-month follow-up period. Major amputations were particularly higher in Group 2 (40%) compared to Group 1 (5%), indicating that higher WIfI stages are associated with increased risk of limb loss (Figure 2).

Figure 2. Comparison of Amputation Outcomes Between Study Groups (n = 70)

Table 2. Comparison of Amputation Outcomes Between Study Groups with Statistical Analysis (n = 70)

*Chi-square test applied. p < 0.05 considered statistically significant.

A statistically significant association was observed between WIfI stage and the incidence of amputation. Patients in Group 2 (WIfI stage 4) had a significantly higher rate of amputation compared to Group 1 (WIfI stages 1–3). Major amputations were particularly more frequent in Group 2 (40%) compared to Group 1 (5%), indicating that higher WIfI stage is strongly associated with increased risk of limb loss (Table 2).

Table 3. Stage-wise Comparison of Amputation Outcomes (WIfI Stages 1–4) (n = 70)

Statistical test: Chi-square test
p-value: < 0.001*
*Statistically significant (p < 0.05)

The incidence of amputation increased progressively with higher WIfI stages. Patients in early stages (Stages 1–2) had lower amputation rates and predominantly minor amputations. In contrast, Stage 4 patients showed the highest incidence of both minor and major amputations, indicating that advanced WIfI stage is strongly associated with increased risk of limb loss in diabetic foot ulcers (Table 3).

Table 4. Summary of Major Amputation Risk According to Individual Components of WIfI Score (n = 70)

The risk of major amputation increased progressively with higher grades of all three WIfI components. Among the wound component, Grade 3 wounds showed the highest risk of major amputation (80%), indicating severe tissue loss significantly increases limb loss risk. Similarly, higher ischemia grades were strongly associated with major amputation, with 66.7% and 71.4% of patients with Ischemia grades 2 and 3 respectively undergoing major amputations. Increasing foot infection severity also showed a rising trend in major amputations, with 41.8% of patients in Infection grade 3 requiring major amputation (Table 4).

Table 5. Diagnostic Accuracy of WIfI Staging System in Predicting Amputation

The predictive ability of the WIfI staging system for amputation was assessed by comparing outcomes between Group 2 (Stage 4) and Group 1 (Stages 1–3). Among patients with Stage 4 disease, 42 out of 50 patients (84%) underwent amputation, whereas only 7 out of 20 patients (35%) in Stages 1–3 required amputation. Conversely, no amputation was observed in 13 patients (65%) in the lower stage group compared to 8 patients (16%) in the Stage 4 group.

Diagnostic Performance of WIfI Scoring System

Diagnostic performance analysis demonstrated that the WIfI scoring system had a sensitivity of 85.7% and specificity of 61.9% for predicting amputation. The positive predictive value was 84%, indicating that most patients classified as Stage 4 eventually required amputation. The negative predictive value was 65%, suggesting that a proportion of patients with lower stages still progressed to amputation. Overall, these findings indicate that higher WIfI stages are strongly associated with increased risk of amputation, supporting the utility of the WIfI classification as a clinically useful tool for predicting limb outcomes in patients with diabetic foot disease.

Table 6. Diagnostic Accuracy of WIfI Staging in Predicting Major Amputation

Diagnostic Performance of WIfI Scoring System

The predictive performance of the WIfI staging system for major amputation was evaluated using a 2×2 contingency analysis. Among patients classified as WIfI Stage 4, 20 out of 50 patients (40%) underwent major amputation, while 30 patients (60%) did not require major amputation. In contrast, only 1 out of 20 patients (5%) in Stages 1–3 progressed to major amputation, whereas 19 patients (95%) in this group did not experience major limb loss.

Diagnostic accuracy analysis demonstrated that the WIfI scoring system had a very high sensitivity of 95%, indicating that most patients who eventually underwent major amputation were correctly identified as having Stage 4 disease. However, the specificity was relatively low (38.7%), suggesting that some patients categorized as high risk did not ultimately require major amputation.

The positive predictive value was 40%, indicating that a proportion of patients with Stage 4 disease progressed to major amputation. In contrast, the negative predictive value was very high (95%), demonstrating that patients with lower WIfI stages (Stages 1–3) had a very low likelihood of major amputation. Overall, these findings indicate that the WIfI staging system is highly sensitive in identifying patients at risk of major limb loss and is particularly valuable for ruling out major amputation in patients with lower WIfI stages.

The present study was conducted to evaluate the role of the Society for Vascular Surgery Wound–Ischemia–Foot Infection (SVS-WIfI) scoring system in predicting amputation among patients with diabetic foot ulcers. The findings demonstrated that higher WIfI stages were associated with a significantly increased risk of amputation, particularly major amputation. Among the 70 patients included in the study, 49 patients (70%) underwent amputation during the 6-month follow-up period, including 28 minor and 21 major amputations. The incidence of amputation was considerably higher in Group-2 (WIfI stage 4) compared with Group-1 (WIfI stages 1–3), suggesting that advanced WIfI stages indicate a greater degree of limb threat.

These findings are consistent with previous studies which have demonstrated that higher WIfI stages correlate strongly with increased risk of limb loss. Studies evaluating the WIfI classification system have reported that the risk of major amputation progressively increases from stage 1 to stage 4, highlighting the usefulness of this system in stratifying limb threat and guiding clinical management (10,11). The WIfI classification system was developed to incorporate three major determinants of limb outcome—wound severity, ischemia, and infection, which together influence the prognosis of diabetic foot ulcers (12).

In the present study, stage-wise analysis showed a progressive increase in amputation risk with increasing WIfI stage. Only 10% of patients in stage 1 underwent amputation, whereas the proportion increased in stages 2 and 3 and reached 84% in stage 4. Major amputations were predominantly observed in patients with advanced stages of disease, indicating that late presentation and severe limb threat significantly increase the risk of limb loss. Similar findings have been reported in recent clinical studies where stage 4 limbs were associated with the highest rates of major amputation and poorest wound healing outcomes (13).

The analysis of individual components of the WIfI scoring system further demonstrated that each component independently influenced amputation risk. Among the wound grades, patients with wound grade 3 showed the highest incidence of major amputation (80%), indicating that deeper and more extensive tissue loss significantly increases the risk of limb loss. Severe tissue destruction and gangrene frequently require surgical intervention and may limit the possibility of limb salvage. Previous studies have similarly reported that advanced wound grades are strongly associated with higher amputation rates (11,13).

The ischemia component also showed a strong association with amputation outcomes. In the present study, all patients with ischemia grades 2 and 3 underwent amputations, with a significant proportion requiring major amputations. Severe ischemia compromises tissue perfusion, delays wound healing, and increases the risk of infection and tissue necrosis. Peripheral arterial disease is widely recognized as a major determinant of limb loss in diabetic foot syndrome, and early vascular assessment and revascularization play an important role in improving limb salvage rates (14).

The foot infection component of the WIfI score also demonstrated a clear relationship with amputation risk. In the present study, none of the patients with infection grade 0 required amputation, whereas 81.4% of patients with infection grade 3 underwent amputations, including a significant number of major amputations. Severe infection leads to rapid tissue destruction and systemic complications and is an important precipitating factor for limb loss. Current international guidelines emphasize that prompt identification and aggressive treatment of diabetic foot infections are essential to prevent amputation (15).

The diagnostic performance analysis in the present study further supports the clinical value of the WIfI scoring system. For predicting overall amputation, the system demonstrated high sensitivity (85.7%) and moderate specificity (61.9%). For predicting major amputation, the sensitivity was even higher (95%) with a negative predictive value of 95%, indicating that patients with lower WIfI stages have a relatively low risk of major limb loss. Similar findings have been reported in recent studies showing that the WIfI classification system has good predictive ability for identifying high-risk limbs and guiding clinical decision-making (16,17).

Overall, the results of the present study are consistent with previous research demonstrating that the WIfI scoring system is a valuable clinical tool for risk stratification in diabetic foot ulcers. By evaluating wound severity, ischemia, and infection simultaneously, the system provides a comprehensive assessment of limb threat and assists clinicians in identifying patients who require early aggressive management.

The present study demonstrates that the SVS-WIfI scoring system is an effective tool for risk stratification in patients with diabetic foot ulcers. Higher WIfI stages were associated with a significantly increased incidence of both minor and major amputations, with stage 4 patients showing the highest risk of limb loss. Analysis of the individual components revealed that increasing wound severity, ischemia, and infection were all associated with worsening outcomes. The WIfI scoring system also showed high sensitivity in predicting amputation and major amputation, making it a useful tool for identifying high-risk patients at an early stage. Therefore, routine use of the SVS-WIfI classification system in clinical practice can assist clinicians in predicting outcomes, guiding treatment decisions, and improving limb salvage in patients with diabetic foot ulcers.

1.      International Diabetes Federation. IDF Diabetes Atlas. 10th ed. Brussels: International Diabetes Federation; 2021.

2.      Anjana RM, Deepa M, Pradeepa R, et al. Prevalence of diabetes and prediabetes in India: Updated estimates from the ICMR-INDIAB study. Lancet Diabetes Endocrinol. 2023;11(3):201-210.

3.      Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med. 2021;384:2367-2375.

4.      Bus SA, Lavery LA, Monteiro-Soares M, et al. Guidelines on the prevention of diabetic foot disease. Diabetes Metab Res Rev. 2023;39(S1):e3507.

5.      Schaper NC, van Netten JJ, Apelqvist J, et al. IWGDF guidelines on the prevention and management of diabetic foot disease. Diabetes Metab Res Rev. 2023;39(S1):e3566.

6.      Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2022;75(1S):3S-125S.

7.      Darling JD, McCallum JC, Soden PA, et al. Predictive value of the SVS WIfI classification system in diabetic foot disease. J Vasc Surg. 2022;75(4):1234-1242.

8.      Hicks CW, Canner JK, Arhuidese IJ, et al. Validation of the WIfI classification system in predicting amputation risk. J Vasc Surg. 2022;76(2):457-465.

9.      Robinson WP, Loretz L, Han J, et al. Clinical outcomes associated with WIfI stage in patients with diabetic foot ulcers. Ann Vasc Surg. 2023;89:214-222.

10.   Senneville E, Lipsky BA, Abbas ZG, Aragón-Sánchez J, Diggle M, Embil JM, et al. Guidelines on the diagnosis and treatment of diabetes-related foot infections. Clin Infect Dis. 2023;76(3):e915-e932.

11.   Cook IO, Jones DW, Davies MG, Bradbury AW, Adam DJ. Clinical utility of the WIfI classification in predicting outcomes in threatened limbs. Ann Vasc Surg. 2024;96:245-253.

12.   Benyakorn T, Jindawatanawong P, Tansakul P, Suwanabol PA. Association between the Society for Vascular Surgery WIfI classification and amputation rate in patients with diabetic foot infection. Int J Low Extrem Wounds. 2024;23(2):152-159.

13.   Haribabu MA, Rao KS, Reddy AV. Clinical outcomes of diabetic foot ulcers using the SVS-WIfI scoring system. J Acad Med Pharm. 2024;6(2):1070-1076.

14.   Rümenapf G, Morbach S, Rother U. Peripheral arterial disease and diabetic foot syndrome: neuropathy makes the difference. J Clin Med. 2024;13(7):2141.

15.   Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers: pathophysiology and management. JAMA. 2023;330(1):62-75.

16.   Huang J, Liu Y, Chen X, Li W, Wang J. Prediction models for amputation in diabetic foot: a systematic review and critical appraisal. Diabetol Metab Syndr. 2024;16:136.

17.   Zhang Y, Liu H, Yang Y, Feng C, Cui L. Incidence and risk factors for amputation in patients with diabetic foot ulcers: a systematic review and meta-analysis. Front Endocrinol (Lausanne). 2024;15:1405301.