Magnesium Supplementation and the Effects on Wound Healing and Metabolic Status in Patients with Diabetic Foot Ulcer: a Randomized, Double-Blind, Placebo-Controlled Trial.

Hypomagnesemia is associated with the development of neuropathy and abnormal platelet activity, both of which are risk factors for diabetic foot ulcer (DFU). This study was carried out to evaluate the effects of magnesium administration on wound healing and metabolic status in subjects with DFU. This randomized, double-blind, placebo-controlled trial was performed among 70 subjects with grade 3 DFU. Subjects were randomly divided into two groups (35 subjects each group) to receive either 250 mg magnesium oxide supplements or placebo daily for 12 weeks. Pre- and post-intervention wound depth and appearance were scored in accordance with the "Wagner-Meggitt's" wound assessment tool. Fasting blood samples were taken at baseline and after the 12-week intervention to assess related markers. After the 12-week treatment, compared with the placebo, magnesium supplementation resulted in a significant increase in serum magnesium (+0.3 ± 0.3 vs. -0.1 ± 0.2 mg/dL, P < 0.001) and significant reductions in ulcer length (-1.8 ± 2.0 vs. -0.9 ± 1.1 cm, P = 0.01), width (-1.6 ± 2.0 vs. -0.8 ± 0.9 cm, P = 0.02), and depth (-0.8 ± 0.8 vs. -0.3 ± 0.5 cm, P = 0.003). In addition, significant reductions in fasting plasma glucose (-45.4 ± 82.6 vs. -10.6 ± 53.7 mg/dL, P = 0.04), serum insulin values (-2.4 ± 5.6 vs. +1.5 ± 9.6 μIU/mL, P = 0.04), and HbA1c (-0.7 ± 1.5 vs. -0.1 ± 0.4%, P = 0.03) and a significant rise in the quantitative insulin sensitivity check index (+0.01 ± 0.01 vs. -0.004 ± 0.02, P = 0.01) were seen following supplementation of magnesium compared with the placebo. Additionally, compared with the placebo, taking magnesium resulted in significant decrease in serum high-sensitivity C-reactive protein (hs-CRP) (-19.6 ± 32.5 vs. -4.8 ± 11.2 mg/L, P = 0.01) and significant increase in plasma total antioxidant capacity (TAC) concentrations (+6.4 ± 65.2 vs. -129.9 ± 208.3 mmol/L, P < 0.001). Overall, magnesium supplementation for 12 weeks among subjects with DFU had beneficial effects on parameters of ulcer size, glucose metabolism, serum hs-CRP, and plasma TAC levels. CLINICAL TRIAL REGISTRATION NUMBER: http://www.irct.ir : IRCT201612225623N96.

RCT Entities:   Population Interventions Outcomes