The beneficial effects of probiotic administration on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double‐blind, placebo‐controlled trial

Abstract Background This study was conducted to evaluate the effects of probiotic supplementation on wound healing and metabolic status in subjects with diabetic foot ulcer (DFU). Methods This randomized, double‐blind, placebo‐controlled trial was conducted among 60 subjects (aged 40‐85 years old) with grade 3 diabetic foot ulcer. Individuals were randomly divided into 2 groups (30 subjects each group) to receive either probiotic or placebo daily for 12 weeks. Results After the 12‐week intervention, compared with the placebo, probiotic supplementation led to significant reductions in ulcer length (−1.3 ± 0.9 vs. −0.8 ± 0.7 cm, P = .01), width (−1.1 ± 0.7 vs. −0.7 ± 0.7 cm, P = .02), and depth (−0.5 ± 0.3 vs. −0.3 ± 0.3 cm, P = .02). Furthermore, significant reductions in fasting plasma glucose (−29.6 ± 30.3 vs. −5.8 ± 39.8 mg/dL, P = .01), serum insulin concentrations (−4.3 ± 7.9 vs. +0.4 ± 8.5 μ IU/mL, P = .03), and haemoglobin A1c (−0.6 ± 0.5 vs. −0.2 ± 0.4%, P = .003) and a significant rise in the quantitative insulin sensitivity check index (+0.01 ± 0.01 vs. −0.01 ± 0.02, P = .003) were seen following supplementation of probiotic compared with the placebo. Additionally, compared with the placebo, probiotic supplementation resulted in significant decreases in serum total cholesterol (−4.8 ± 16.1 vs. +7.0 ± 27.1 mg/dL, P = .04), high‐sensitivity C‐reactive protein (−9.0 ± 14.7 vs. −1.7 ± 8.6 mg/L, P = .02), plasma malondialdehyde (−0.8 ± 0.8 vs. −0.2 ± 0.8 μ mol/L, P = .001), and significant increases in plasma nitric oxide (+6.2 ± 8.2 vs. +0.8 ± 8.0 μ mol/L, P = .01) and total antioxidant capacity concentrations (+179.3 ± 97.2 vs. −85.1 ± 203.4 mmol/L, P < .001). Conclusions Overall, probiotic supplementation for 12 weeks among subjects with diabetic foot ulcer had beneficial effects on ulcer size, glycaemic control, total cholesterol, high‐sensitivity C‐reactive protein, plasma nitric oxide, total antioxidant capacity, and malondialdehyde levels.