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Published on: March 3, 2023
Real-World Effectiveness and Dose-Response of ON101 Therapy for Healing of Diabetic Foot Ulcers
Shun-Cheng Chang1, Chen-Yi Yang2, Ching-Uen Huang3
1Division of Plastic Surgery, Integrated Burn & Wound Care Center, Department of Surgery, Shuang-Ho Hospital, New Taipei City, Taiwan; Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
Objective:
To evaluate the real-world effectiveness and dose-response of ON101 , especially for high-risk patients with poor healing outcomes.
Patients And Methods:
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.
Results:
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).
Conclusion:
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.
Insights
ON101 cream significantly improved diabetic foot ulcer healing in a real-world study. Lower doses showed effectiveness, particularly for high-risk patients, suggesting practical benefits for routine care.
Area of Science:
- Dermatology and Wound Healing
- Pharmacology and Therapeutics
Background:
- Diabetic foot ulcers (DFUs) represent a significant clinical challenge with poor healing outcomes.
- ON101 cream is a novel therapeutic agent designed to modulate macrophage function and promote anti-inflammatory properties for wound healing.
Purpose of the Study:
- To assess the real-world effectiveness and dose-response relationship of ON101 cream in treating diabetic foot ulcers.
- To specifically evaluate the efficacy of ON101 in high-risk patient populations with compromised healing.
Main Methods:
- A retrospective study identified 80 patients treated with ON101 and 98 with standard care (nonuse) for DFUs between 2020-2022.
- The primary outcome was complete ulcer healing within 120 days; secondary outcomes included recurrence, amputation, and mortality.
- Cox proportional hazard models and regression analysis were used to evaluate treatment effects and dose-response.
Main Results:
- ON101 use was associated with a 79% increase in complete healing compared to nonuse (HR 1.79).
- Consistent positive healing outcomes were observed in high-risk patient subgroups.
- Dose-response analysis indicated significant decreases in ulcer size with increased ON101 tube usage across different Wagner grades.
Conclusions:
- ON101 therapy demonstrates promising real-world effectiveness for diabetic foot ulcer healing, even at lower doses.
- The study supports the potential therapeutic benefit of ON101 for patients with poor prognoses and its feasibility in clinical practice.
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