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.

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 µIU/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 µmol/L, P = .001), and significant increases in plasma nitric oxide (+6.2 ± 8.2 vs. +0.8 ± 8.0 µmol/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.