Key points- ✔ 50 patient double-blind, placebo-controlled, parallel series, randomized controlled trial (RCT)
- ✔ Study prematurely terminated after the completion of the first 20 cases, because of the significant superiority of the active treatment arm of STIMULAN with an antibiotic.
- ✔ The patient in the placebo group who experienced a DFO recurrence underwent a new surgical procedure (after breaking the blinding code), using STIMULAN with tobramycin and achieved complete healing after 2 months.
- ✔ Analysis of direct costs show no significant difference between antibiotic loaded STIMULAN and traditional approaches.
Summary A new study by Monami et al. (2025), titled ”Efficacy and Safety of a Bio-absorbable Antibiotic Delivery in Calcium sulfate Granules for the Treatment of Osteomyelitis in Patients with Diabetic Foot: A Randomized, Double-Blinded, Controlled Clinical Study”, investigated the safety and efficacy of antibiotic-impregnated calcium sulfate granules (STIMULAN) in managing diabetic foot osteomyelitis (DFO). This double-blind, placebo-controlled trial included 20 patients with diabetes presenting with foot ulcers complicated by osteomyelitis (Texas grade 3) with deep soft tissue infections. Participants were randomised to receive either antibiotic-loaded calcium sulfate granules (STIMULAN with either tobramycin or vancomycin) or placebo granules without antibiotics during surgical intervention. The primary endpoint was the percentage of infective complications (composite end point of dehiscence, infection, DFO recurrence and new DFO in adjacent site) at 12 weeks. The trial was prematurely terminated due to the significant superiority of the active treatment arm. No infections occurred in the antibiotic-impregnated STIMULAN group, whereas all post-surgical infections were observed in the placebo group, yielding a statistically significant difference (p = 0.010). Additionally, there was no significant cost difference between the treatment and placebo groups, suggesting economic sustainability of this approach. This study by Monami and colleagues suggests that the use of antibiotic impregnated STIMULAN might be economically sustainable and has the potential of improving the prognosis of diabetic foot osteomyelitis.
Publication https://pubmed.ncbi.nlm.nih.gov/39972526/ 