Efficacy Of N-Acetyl-Cysteine as Adjuvant Therapy for Diabetic Foot Osteomyelitis: An Open-Label Randomized Controlled Trial.

Abstract

Background: Biofilm formation by bacteria on the lower limb arises from reduced peripheral arterial blood flow, which can lead to the failure of antibiotic therapy or require longer duration of intravenous antibiotic therapy in diabetic foot infection-associated osteomyelitis. N-acetyl cysteine (NAC), an agent known to prevent and treat biofilm-related infections, was used as a novel strategies beside antibiotic therapy in osteomyelitis of diabetic foot with the aim of accelerating the response to antibiotic therapy regimen.

Methods: To assess the synergistic effect of NAC with antibiotic therapy, patients with diabetic foot osteomyelitis (DFO) (grade III or IV Wagner) were randomly assigned to either NAC 600 mg effervescent tablet twice daily for 2 weeks or the control group. Clinical and laboratory data, including white blood cell with differentiation and inflammatory factors (ESR and CRP) were measured at baseline (time 0), after one week and after three weeks of initiating the intervention.

Results: Fifty-three eligible patients completed the study. All evaluated infectious-related laboratory parameters showed significant reductions in the NAC group compared to control (P<0.05), except for lymphocyte proportion and NLR (P; 0.11 and 0.84, respectively). The drop rate of ESR and CRP were accelerated by NAC compared to the control group (-49.44±6.04 vs -7.17±3.99; -44.43±4.21 vs -14.02±4.05, respectively, P<0.05).

Conclusion: In order to accelerate antibiotic responses and the trend of reduction in infectious inflammatory markers during the therapy, oral NAC 600 mg twice daily may be considered in the treatment protocol of patients with DFO.