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: