Real-World Effectiveness and Dose-Response of ON101 Therapy for Healing of Diabetic Foot Ulcers.

Abstract

To evaluate the real-world effectiveness and dose-response of ON101 , especially for high-risk patients with poor healing outcomes. ON101 cream, a novel treatment for diabetic foot ulcers (DFUs), modulates the function of macrophages and accelerates the emergence and expansion of anti-inflammatory properties. In this study, 80 and 98 patients with DFU who were treated using ON101 and standard care with adjuvant therapy (denoted as nonuse), respectively, from January 1, 2020, to December 31, 2022, were identified from Taipei Medical University-Shuang Ho Hospital, Taiwan. The primary outcome was a complete healing event within 120 days following treatment initiation. Secondary outcomes included ulcer recurrence, amputation, and all-cause mortality within 1 year of follow-up. Cox proportional hazard model analysis was applied to determine the treatment effect on study outcomes. The dose-response of ON101 on healing outcomes was modeled using a regression analysis. Compared with nonuse, ON101 use significantly increased the complete healing outcome by 79% (HR, 1.79; 95% CI, 1.24 to 2.58), with an average of 1.85 ON101 tubes used per person with healed ulcers. Favorable healing outcomes were consistently shown in the analyses of high-risk patients. The dose-response analysis results suggest 25%, 107%, 33%, and 19% decreases in the ulcer size per additional ON101 tube use for all study patients and those with Wagner grade 1, 2, and 3 ulcers, respectively (all P<.01). Promising healing outcomes following ON101 therapy at lower doses among real-world patients with DFU are corroborated, with a potential therapeutic benefit for clinically disadvantaged patients and practical feasibility for use in routine practice.