A study by Huang, YY, et al. reported that topical treatment with ON101 resulted in improved healing of diabetic foot ulcers (DFUs) compared to standard care. The study was a randomized phase 3 clinical trial of 236 patients with DFUs. A topical application of ON101 with gauze immediately after debridement demonstrated significant healing efficacy compared with an absorbent dressing in all patients (Hydrofiber; ConvaTec Ltd), including those with DFU-related risk factors. Delayed healing of DFUs is known to be caused by dysregulated M1/M2-type macrophages. Restoring the balance between these macrophage types plays a critical role in healing. Drugs used to regulate M1/M2 macrophages have not yet been studied in large randomized clinical trials.

This study was a multicenter randomized clinical trial. Eligible patients with debrided DFUs of 1 to 25 cm² present for at least 4 weeks and with Wagner grade 1 or 2 were randomized 1:1 to receive ON101 or control absorbent dressings. ON101 exhibited better healing efficacy than absorbent dressing alone in the treatment of DFUs and showed consistent efficacy among all patients, including those with DFU-related risk factors (glycated hemoglobin level, ≥9%; ulcer area, >5 cm²; and DFU duration, ≥6 months). No treatment-related serious adverse events occurred in the ON101 group vs 1 (0.9%) in the comparative group.

Leonard A. Levy, DPM, MPH, Ft. Lauderdale, FL