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

Results / Discussion

• The use of ON101 significantly increased complete healing of the target ulcer by 79% compared to current best care group (80% vs. 55%, HR: 1.79, 95% CI, P=0.0017). Subgroup analyses consistently demonstrated a significant complete healing rate of ON101 across Wagner grade 2 patients (90% vs. 65%, HR=1.78, P=0.0044); infected patients classified as IDSA 2/3 (76% vs. 23%, HR=5.46, P<0.0001). Specifically, for IDSA 2 infections, ON101 treatment resulted in 83% healing rate vs. 25% in current best care group (HR=6.21, P<0.0001).
• Notably, in Wagner grade 1 DFU patients, ON101 exhibited superior and faster healing, achieving a 100% complete healing rate within one month, vs. none healing in the comparator group during the same period (P=0.001).
• Amputation rates within one year of follow-up were significantly lower in the healed patients by ON101 (0% [0/64] vs. 7.41% [4/54], P=0.041).
• The average ON101 consumption per patient was 1, 1.98, and 2.56 tubes for Wagner grade 1, 2, and 3 ulcers, respectively.

Conclusion

Promising healing outcomes following ON101 therapy at lower doses among real-world DFU patients are corroborated, with a potential therapeutic benefit for clinically disadvantaged patients and practical feasibility for use in routine practice.