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Abstract

Background: Diabetic foot ulcers (DFUs) represent one of the most serious complications of diabetes mellitus, leading to prolonged morbidity, reduced quality of life, and an increased risk of lower limb amputation. India, being home to one of the highest populations of diabetics globally, faces a growing burden of DFUs. Conventional dressing has been the standard treatment for DFUs, but it is associated with prolonged healing time and a substantial risk of infection. Vacuum-Assisted Closure (VAC) therapy, a negative pressure wound therapy (NPWT), has emerged as a promising alternative for faster wound healing. By promoting angiogenesis, reducing bacterial load, and enhancing granulation tissue formation, VAC therapy may significantly improve outcomes in DFU patients. This study aims to compare the efficacy and safety of VAC therapy against conventional dressing in terms of wound healing time, granulation tissue formation, and associated complications.
Objectives: The primary objective of this study was to evaluate the effectiveness of VAC therapy compared to conventional dressing in achieving complete wound healing in DFU patients. Secondary objectives included assessing the rate of granulation tissue formation, reduction in ulcer size, pain perception, infection rates, and the incidence of complications such as bleeding and minor amputations.
Methods: A prospective, randomized controlled trial was conducted at a tertiary care hospital in India between November 2022 and December 2023. A total of 54 patients diagnosed with DFU and fulfilling the inclusion criteria were enrolled and randomized into two groups: the VAC therapy group (n=27) and the conventional dressing group (n=27). Baseline characteristics, including age, gender, Wagner classification, and comorbidities, were recorded. VAC therapy was applied with negative pressure maintained at 125 mmHg, and dressings were changed every 3–5 days. The conventional dressing group underwent saline-moistened gauze dressings changed daily. Wound healing was assessed using granulation tissue visual scores, reduction in ulcer size, and time to complete epithelialization. Pain was evaluated using the Visual Analog Scale (VAS), and infection rates were documented. Statistical analysis was performed using SPSS version 22, with a p-value of <0.05 considered significant.
Results: Patients in the VAC therapy group demonstrated a significantly shorter wound healing time (mean 24.3 ± 5.1 days) compared to the conventional dressing group (mean 39.8 ± 6.4 days, p<0.001). The mean granulation tissue formation rate was higher in the VAC group (2.3 cm²/day) than in the conventional dressing group (1.4 cm²/day, p=0.002). A significantly greater percentage reduction in ulcer area was observed in the VAC group (74.5%) than in the conventional dressing group (48.7%, p<0.001). Pain scores (VAS) at 24 and 48 hours were lower in the VAC therapy group (p<0.05), indicating better pain control. Infection rates were also reduced in the VAC group (14.8%) compared to the conventional dressing group (29.6%, p=0.03). The incidence of bleeding and minor amputations did not differ significantly between the groups.
Conclusion: This study demonstrates that VAC therapy significantly enhances wound healing in DFU patients compared to conventional dressing by promoting faster granulation tissue formation, reducing infection rates, and decreasing overall healing time. Additionally, VAC therapy was associated with better pain control, contributing to improved patient compliance and comfort. Given these benefits, VAC therapy should be considered a superior alternative to conventional dressing for DFU management. Future studies with larger sample sizes and longer follow-up periods are warranted to further validate these findings.