Accumulating scientific evidence has revealed that targeting macrophage phenotypes might be a potentially effective therapy in DFUs because hyperglycemia increases the ratio of proinflammatory M1 to pro-regenerative M2 macrophages. This study is the first international Phase 3 randomized clinical trial of an investigation drug able to regulate M1/M2 macrophage activities in the patients with diabetic foot ulcers (DFUs). The investigational compound has been given a research code: ON101 (trade name: Fespixon) has demonstrated the clinical superiority to the standard care (an absorbent dressing). The primary endpoint, complete healing, was found in 60.7% of the ON101 group and 35.1% of the comparison group during the treatment period (p=0.0001). Time to complete healing, the secondary endpoint, was faster in the ON101 group (p=0.002). The researchers have reported that “Topical application of ON101 with gauze … read more