Successful Healing of a Chronic Distal Toe Ulcer with Tendon Exposure Using the Topical Macrophage Regulator ON101

Diabetic foot ulcer (DFU) is one of the most challenging complications of diabetes mellitus. Chronic hyperglycemia contributes to impaired immune function, characterized by failure of macrophage polarization from the proinflammatory M1 to the prohealing M2 phenotype, together with increased release of inflammatory mediators. ON101 is a novel macrophage-regulating topical agent derived from botanical extracts, designed to suppress proinflammatory cytokines, restore M1/M2 macrophage balance, and promote collagen synthesis. We report the case of a 77-year-old man with diabetes mellitus who presented with a chronic, nonhealing ulcer of the right fifth toe with exposed tendon, persisting for 2 years despite conventional wound care and twice-daily Aquacel Ag⁺ extra dressing changes. The wound was accompanied by local inflammation, whereas angiographic evaluation suggested preserved distal runoff without evidence of critical macrovascular occlusion. ON101 topical therapy was initiated once daily under PolyMen dressing, leading to progressive granulation tissue formation, epithelial coverage of the tendon, and complete wound closure within 2 months. Notably, the total amount of ON101 used throughout the treatment course was less than 1 15-g tube. Given the chronicity of the wound, the presence of exposed tendon, and the difficulty of achieving durable healing in distal diabetic toe ulcers, this case suggests that ON101 may provide substantial therapeutic benefit in selected refractory cases.