Simplified Manual Vacuum Dressing versus Conventional Saline Dressing in Chronic Non-Healing Foot Ulcers: A Randomized Controlled Trial

Background: Chronic non-healing foot ulcers, predominantly in patients with diabetes, impose a heavy burden of prolonged hospitalization, recurrent infection, and risk of amputation. Although negative-pressure wound therapy (NPWT) accelerates healing, commercial systems remain inaccessible in most public hospitals of lowresource settings. This trial evaluated whether a simplified manual vacuum dressing assembled from readily available materials could replicate the benefits of NPWT while remaining affordable and reproducible. Methods: In a single-center, prospective, randomized controlled trial conducted at the Department of General Surgery, Government Erode Medical College and Hospital, Tamil Nadu, India, 50 adults (20–75 years) with chronic foot ulcers were allocated 1:1 by simple randomization to either simplified manual vacuum dressing (Group A, n=25) or conventional saline-antiseptic dressing (Group B, n=25). The intervention dressing comprised sterile gauze, a Ryle’s tube or suction catheter, transparent adhesive film, and wall suction to deliver continuous sub-atmospheric pressure. Primary outcomes were granulation tissue coverage (visual scoring), necrotic tissue clearance, and ulcer area reduction. Secondary outcomes included time to granulation, hospital stay, and complication rates. Assessments were performed daily until discharge; data were analyzed with SPSS version 25 using independent t-tests for continuous variables and χ² tests for categorical variables (p < 0.05 significant). Results: Groups were comparable at baseline (mean age 57.0 ± 14.85 vs 55.0 ± 14.45 years; 84% vs 76% diabetic). At study end, 44% of vacuum-dressed wounds achieved 75–100% granulation versus 12% in the control group (p = 0.03). Necrotic tissue clearance was superior (p = 0.04), final ulcer area was markedly smaller (2.4 ± 1.2 cm² vs 4.9 ± 1.8 cm², p = 0.002), time to granulation was shorter (9.2 ± 2.1 vs 14.1 ± 3.5 days, p = 0.001), and hospital stay was reduced (15.4 ± 3.2 vs 21.7 ± 4.1 days, p = 0.001). Infection (12% vs 40%, p = 0.02) and excess exudate (12% vs 48%, p = 0.008) were significantly lower in the intervention arm. Conclusion: Simplified manual vacuum dressing is a safe, effective, and dramatically cost-efficient alternative to conventional care and commercial NPWT. Its adoption could transform wound management in resource-limited environments without compromising clinical outcomes.