European Journal of Cardiovascular Medicine

Chronic venous leg ulcer (CVLU) is defined as an open sore between the knee and ankle that fails to heal for at least six weeks and occurs in the presence of venous disease [1]. These ulcers develop due to venous valve incompetence and are most frequently seen on the lower limbs, particularly along the medial aspect near the ankle [2]. They are painful, recurrent, and significantly impair quality of life. Venous ulcers account for approximately 60–80% of all leg ulcers [3]. In the United Kingdom, the estimated prevalence ranges from 0.1% to 0.3%, increasing sharply with advancing age [4], and nearly 1% of the population experiences a leg ulcer during their lifetime [5]. The pathophysiology involves venous reflux and calf muscle pump insufficiency, leading to venous hypertension, microcirculatory changes, and local tissue ischemia [6].

The disease follows a chronic course characterized by alternating periods of healing and recurrence, resulting in considerable morbidity and reduced quality of life [7]. The economic burden is also substantial—annual treatment costs per patient have been estimated between ₹36,719 and ₹2,75,000 in India [8]. According to NHS data, community-based management achieves a 45% healing rate in six months, while specialized leg ulcer clinics report 70% healing in the same period; however, recurrence rates within a year remain between 26% and 69% [9]. Typical clinical manifestations include swelling, pain, bleeding, and stasis dermatitis [10].

Management of venous ulcers includes both conservative and surgical modalities. Conservative treatment involves leg elevation, bed rest, regular wound dressings, compression therapy, debridement, and sometimes skin grafting [11]. Compression therapy remains the gold standard; by applying graded pressure—highest at the ankle and decreasing toward the knee—it enhances venous return and reduces reflux [12]. Surgical management addresses the underlying venous incompetence and includes superficial and perforator vein ablation, subfascial endoscopic perforator surgery (SEPS), ligation and stripping, and minimally invasive options such as laser ablation, radiofrequency treatment, and sclerotherapy [13]. Although superficial vein surgery has not been shown to hasten ulcer healing, it significantly reduces recurrence when deep veins remain competent [24]. The ESCHAR trial further demonstrated that combining surgery with compression almost halved recurrence rates compared with compression alone [14].

If inadequately treated, venous ulcers may progress to chronic, non-healing wounds that cause immobility, cellulitis, osteomyelitis, and even malignant transformation [15]. Considering the chronicity, recurrence, and high cost associated with this condition, the present prospective comparative study was undertaken to evaluate and compare the outcomes of conservative versus surgical interventions in the management of venous leg ulcers.

The aim of the present study was to evaluate and compare the outcomes of conservative and surgical management in patients with venous leg ulcers, with a focus on the rate and extent of ulcer healing. The study sought to assess how each approach influenced the reduction in ulcer size and the overall healing process over time. Specifically, it aimed to analyze changes in ulcer dimensions after one month, two months, and six months of treatment in both groups to determine which modality provided faster and more effective healing. By systematically comparing conservative modalities such as wound dressing, compression therapy, and sclerotherapy with surgical interventions like ligation, stripping, and subfascial perforator ligation, the study intended to identify the more beneficial approach for improving clinical outcomes and reducing recurrence rates in chronic venous leg ulcer management.

Study Design and Setting

This prospective comparative study was conducted in the Department of General Surgery, Deccan College of Medical Sciences, Kanchanbagh, Hyderabad, over a period of 18 months from November 2022 to April 2024. The study aimed to evaluate and compare the outcomes of conservative and surgical management in patients with chronic venous leg ulcers. A total of 60 patients of either gender who met the inclusion criteria were enrolled. Ethical clearance was obtained from the Institutional Review Board, and written informed consent was taken from all participants before enrollment.

Sample Size

The sample size was calculated using the formula:

n = 1.96 × 1.96 × pq / d²,

where p represents the estimated prevalence (3%), q = 100 – p, and d is the allowable error (5–10% of p). Based on this, the minimum required sample size was 45 patients. For better statistical validity, the study included 60 patients, who were equally divided into two groups —

Group I (Conservative Management): 30 patients treated with non-surgical methods such as dressing, compression therapy, and sclerotherapy.

Group II (Surgical Management): 30 patients treated surgically by ligation and stripping of varicose veins or subfascial perforator ligation.

Inclusion Criteria

• Male and female patients with venous ulcers associated with varicose veins.

Exclusion Criteria

• Patients with venous ulcers due to acute deep vein thrombosis.
• Patients with peripheral vascular disease causing critical limb ischemia.
• Patients with immunocompromised conditions such as malignancy, HIV, diabetes mellitus, tuberculosis, or leprosy, or those on long-term corticosteroid therapy.

Methodology

Patients diagnosed with venous ulcers and meeting the inclusion criteria were allocated to one of the two treatment groups. Group I received conservative management, including regular wound dressings, compression bandaging, and sclerotherapy as indicated. Group II underwent surgical intervention, involving procedures such as ligation and stripping of incompetent veins or subfascial perforator ligation. All patients were followed up for six months, during which ulcer healing, reduction in size, and other clinical outcomes were systematically recorded. The surface area of each ulcer was measured initially and at subsequent intervals (1 month, 2 months, and 6 months) to assess the rate of healing.

Statistical Analysis

Data obtained were analyzed using both descriptive and inferential statistics. Results were expressed as frequency, percentage, mean ± standard deviation (SD). Comparative analyses between groups were performed using appropriate statistical tests (Chi-square test, unpaired t-test, and ANOVA), with p < 0.05 considered statistically significant

Figure 1: Age-wise Distribution in the Study Groups (20–70 years)

The age-wise distribution graph illustrates that the majority of patients in both study groups fall within the 51–60 years age range, representing 50% of the conservative group and 56.7% of the surgical group. A smaller proportion of patients belonged to the 41–50 years category (10% in the conservative and 20% in the surgical group), while very few were under 40 years.

Patients aged 61–70 years comprised 36.7% of the conservative group and 23.3% of the surgical group.

Table 1: Distribution of Study Population Based on Mean Age, Gender, and Group Classification

Table 1 shows that the mean age of patients in the conservative group was 58.4 ± 7.43 years, while in the surgical group it was 56.1 ± 5.66 years. The p-value of 0.1832 indicates that there was no statistically significant difference between the two groups in terms of mean age, confirming that both groups were comparable in their age distribution.

In terms of gender, males formed the majority in both groups, accounting for 70% in the conservative group and 60% in the surgical group, while females comprised 30% and 40%, respectively. This suggests a male predominance among the study participants and a balanced gender distribution across both groups, minimizing demographic bias in the comparison of treatment outcomes.

Figure 2: Distribution of Patients Based on Site of Ulcer

The pie charts show the distribution of venous ulcer sites in both treatment groups.

In the conservative group, the medial malleolus was the predominant site, accounting for 83.3% of cases, while the back of the ankle represented 16.7%. Similarly, in the surgical group, 80% of ulcers were located at the medial malleolus, and 20% at the back of the ankle.

This pattern demonstrates that the medial malleolus is the most common site for venous ulcers in both groups, consistent with the typical pathophysiology of venous stasis leading to ulceration at the lower medial aspect of the leg. The difference between the two groups was statistically insignificant (p = 0.9427), indicating a comparable distribution of ulcer sites across treatment groups.

Table 2: Distribution of Study Population Based on Infection Status of the Venous Ulcer

The table 2 shows that infection of the wound was present in 5 patients (16.6%) from the conservative group and 7 patients (23.3%) from the surgical group, totaling 12 infected cases (20%) across the study population.

In contrast, the majority of patients 25 (83.4%) in the conservative group and 23 (76.7%) in the surgical group had no infection, making up 48 cases (80%) in total. The chi-square test results (p = 0.5186 and p = 0.7469) show no statistically significant difference in infection rates between the two groups.

Figure 3: Distribution of Patients According to Duration of Hospital Stay in the Study Groups

The figure 3 illustrates the distribution of patients based on the duration of hospital stay in both the conservative and surgical management groups. It shows that the majority of patients in both groups remained hospitalized for 16–20 days—63.3% in the conservative group and 66.6% in the surgical group. A smaller number of patients had shorter hospital stays of 6–10 days (23.3% in both groups), while only a few stayed for 11–15 days (13.3% in the conservative and 10% in the surgical group).

Table 3: Distribution of Study Population Based on Types of Conservative and Surgical Management of Venous Ulcer

The table 3 shows the distribution of patients based on different types of conservative and surgical management of venous ulcers. In the conservative management group (Group I), compression therapy was the most frequently used treatment modality, accounting for 53.3% of cases, followed by regular wound dressing (30%), and sclerotherapy (16.7%). In the surgical management group (Group II), both ligation and stripping and open subfascial ligation for perforator incompetence were performed in equal proportions (50% each).

Figure 4: Distribution of Study Population Based on Saphenofemoral Junction Incompetence

The figure 4 illustrates the distribution of saphenofemoral junction incompetence among patients in both treatment groups. In the conservative group, incompetence was present in 7 patients (23.3%) and absent in 23 patients (76.7%), whereas in the surgical group, it was present in 12 patients (40%) and absent in 18 patients (60%). Although saphenofemoral junction incompetence appeared slightly more common in the surgical group, the difference was not statistically significant (p = 0.1652).

Table 4: Distribution of Study Population Based on Number of Incompetent Perforators Above and Below Knee

The table 4 shows the distribution of incompetent perforators above and below the knee among patients in the conservative and surgical groups.

For incompetent perforators above the knee, 6 patients (20%) in the conservative group and 9 patients (30%) in the surgical group were affected. Similarly, for incompetent perforators below the knee, incompetence was seen in 18 patients (60%) in the conservative group and 21 patients (70%) in the surgical group. The chi-square test results for both above-knee (p = 0.3711) and below-knee (p = 0.4168) perforators indicate no statistically significant difference between the two groups.

Table 5: Comparison between Conservative and Surgical Management Based on Duration and Size of Ulcer

The table 5 compares the duration and size of venous ulcers between the conservative and surgical management groups using the unpaired t-test.

The mean duration of ulcer was significantly longer in the surgical group (119.96 ± 37.21 days) compared to the conservative group (39.56 ± 7.81 days), indicating that surgical intervention was primarily considered for chronic and long-standing ulcers.

The initial ulcer size was also greater in the surgical group (80.36 ± 23.23 mm) compared to the conservative group (42.66 ± 5.76 mm), with a statistically significant difference (P < 0.0001).

Over the course of treatment, there was a progressive reduction in ulcer size in both groups. After one month, the mean ulcer size reduced to 49.33 ± 16.73 mm in the surgical group and 30.73 ± 4.69 mm in the conservative group. After two months, the ulcer size further reduced to 12.73 ± 2.85 mm in the surgical group and 27.73 ± 4.73 mm in the conservative group.

All parameters showed statistically significant differences (P < 0.0001), reflecting that although surgical patients initially had larger and longer-duration ulcers, surgical management led to a more rapid and significant reduction in ulcer size compared to conservative treatment.

Table 6: Rate of Decrease in Size of Venous Ulcer Treated Conservatively After 1 Month and 2 Months (Group I)

The mean initial ulcer size was 42.66 ± 5.76 mm, which reduced to 30.73 ± 4.69 mm after one month and 27.73 ± 4.73 mm after two months of conservative treatment.

The ANOVA analysis revealed a statistically significant reduction in ulcer size between the initial measurement and after one month (p < 0.0001) as well as between the initial measurement and after two months (p = 0.0001).

However, the difference in ulcer size between the first and second months was not statistically significant (p = 0.0877), indicating that the major healing occurred within the first month, followed by a slower rate of improvement thereafter.

Table 7: Rate of Decrease in Size of Venous Ulcer Treated Surgically After 1 Month and 2 Months (Group II)

The table 7 shows mean initial ulcer size was 80.36 ± 23.23 mm, which markedly reduced to 49.33 ± 16.73 mm after one month and further decreased to 12.73 ± 2.85 mm after two months following surgery.

The ANOVA test results indicate a highly significant reduction in ulcer size across all intervals:

• From baseline to one month (p < 0.0001),
• From baseline to two months (p < 0.0001), and
• From one month to two months (p = 0.0001).

These results confirm that surgical intervention leads to a rapid and continuous reduction in ulcer size throughout the healing period.

Figure 5: Association between Conservative and Surgical Management Based on Healing of Venous Ulcer after 6 Months

The figure 5 compares the ulcer healing outcomes between the conservative and surgical management groups after six months of treatment. It shows that 27 patients (90%) in the surgical group achieved complete ulcer healing, compared to 19 patients (63.3%) in the conservative group. Conversely, non-healing was observed in 11 patients (36.7%) in the conservative group and only 3 patients (10%) in the surgical group. The difference is statistically significant (p = 0.0146), indicating that surgical management led to faster and more complete ulcer healing compared to conservative methods. This clearly demonstrates the superiority of surgical intervention in promoting recovery and reducing chronicity in venous ulcers.

Venous ulceration is a chronic, debilitating condition that often results in repeated hospitalizations due to recurrent ulcer formation despite initial healing with rest and limb elevation. The present study compared the outcomes of conservative and surgical management in patients with venous leg ulcers to determine which approach provides more effective and sustained healing.

In this study, the majority of patients in both groups belonged to the 51–60 years age group (50% in the conservative group and 56.7% in the surgical group), followed by those aged 61–70 years. The mean age of patients was 58.4 ± 7.43 years in the conservative group and 56.1 ± 5.66 years in the surgical group, showing no statistically significant difference between the two. The findings are consistent with studies by Kumar S et al., and Van Gent WB et al., (11, 16) who reported a similar age distribution, suggesting that venous ulcers predominantly affect middle-aged and elderly individuals. In the present study, males were more frequently affected (68.3%) than females (31.7%), aligning with several previous studies that reported a higher male preponderance, attributed to occupational and lifestyle factors involving prolonged standing.

The medial malleolus was the most common site of ulceration, seen in 83.3% of the conservative group and 80% of the surgical group, which corresponds with earlier findings by Vignesh T et al. and Arun S et al. (17, 18) describing the “Gaiter’s area” as the most frequently affected region. Infection rates were slightly higher in the surgical group (23.3%) compared to the conservative group (16.6%), but the difference was statistically insignificant, indicating that both treatment modalities maintained good wound hygiene. The duration of hospital stay was similar between groups, with most patients (over 60%) in both categories staying 16–20 days, again without significant difference.

Anatomically, saphenofemoral junction (SFJ) incompetence was observed in 23.3% of the conservative group and 40% of the surgical group, while incompetent perforators above and below the knee were slightly more frequent in surgically managed patients. Among conservatively treated patients, 53.3% received compression therapy, 30% underwent regular wound dressing, and 16.7% received sclerotherapy. In contrast, surgical interventions included ligation and stripping of the long saphenous vein or open subfascial perforator ligation, each performed in 50% of patients.

The comparison of ulcer size revealed a statistically significant reduction (p < 0.0001) favoring surgical management. The mean ulcer size was 80.36 ± 23.23 mm in the surgical group and 42.66 ± 5.76 mm in the conservative group initially. After one month, the mean size reduced to 49.33 ± 16.73 mm (surgical) and 30.73 ± 4.69 mm (conservative), and by two months, to 12.73 ± 2.85 mm and 27.73 ± 4.73 mm, respectively. Both groups showed significant healing at one month, but the surgical group demonstrated a continued and more rapid improvement by two months. ANOVA testing confirmed significant changes in ulcer size at all time points in surgically managed patients (p < 0.0001), whereas conservative management showed slower progress after the first month (p = 0.0877).

After six months, ulcer healing outcomes were markedly better in the surgical group, with 90% complete healing compared to 63.3% in the conservative group (p = 0.0146, statistically significant). These findings corroborate earlier studies by Van Gent WB et al., (11) which demonstrated that surgical correction of venous incompetence—when combined with compression achieves faster and more sustained ulcer healing with fewer recurrences. Similarly, studies by Vranic H et al., and Khairy MM et al. (19, 20) have reinforced the superiority of combining surgery with compression therapy over conservative management alone

This study shows that both conservative and surgical approaches contribute to meaningful improvement in venous leg ulcers, but surgical management offers a clear advantage in terms of healing speed and long-term outcomes. The surgical group demonstrated faster and more sustained reduction in ulcer size, significant improvement beyond the first month, and a markedly higher complete-healing rate at six months compared to the conservative group. These results support the view that correcting venous reflux through appropriate surgical intervention, when combined with standard compression therapy, leads to better ulcer resolution and reduces the likelihood of recurrence. While conservative measures remain important for symptom control and early management, timely surgical treatment provides more durable benefits and improves overall quality of life for patients suffering from chronic venous ulceration.

Conflict of interest: None declared.

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