Non-Randomised Comparative Analysis and Cost-Minimisation Analysis of Macrophage-Modulating Cream on Mildly Infected...

Diabetic foot ulcers (DFUs) are serious complications of diabetes, characterised by impaired healing driven in part by pro-inflammatory macrophage activity. ON101, a topical macrophage-modulating cream, promotes M1-to-M2 transition and improves wound healing. We prospectively enrolled patients with Wagner Grade 2 DFUs and mild infection per the Infectious Diseases Society of America criteria to receive ON101 with weekly follow-up. Exclusions included dialysis dependence and inadequate arterial perfusion. The primary endpoint was a 4-week healing outcome. The secondary analysis compared direct costs to a 1:1 retrospective standard of care cohort matched on wound locations and natural history. A total of 12 cases were analysed (mean age: 65.8 years in the ON101 group; 64.6 years old in the control group, p = 0.957). No adverse events occurred. The mean paired difference at the 4-week healing outcome of ON101 was an 87% reduction (95% bootstrap CI: 9.0-244.0) versus the control group. Direct cost per wound healed was approximately 19% lower with ON101. Subjects receiving ON101 demonstrated a significantly faster wound-healing rate within 4 weeks. The direct cost difference between ON101 and SOC mirrored lower resource use. A larger, randomised study with longer follow-up is required to determine the robustness, generalisability and durability of these preliminary results.