ON101, a topical cream, has demonstrated superior efficacy compared to conventional dressings in healing diabetic foot ulcers (DFUs), particularly in patients with risk factors that make their ulcers difficult to heal. These findings come from a post-hoc analysis of a phase 3 clinical trial, offering a potential advancement in DFU treatment.
The original phase 3 trial (NCT01898923) and a new cohort study evaluated ON101 against absorbent dressings in patients with Wagner grade 1 or 2 DFUs. The analysis included 276 patients, with 141 receiving ON101 and 135 receiving conventional dressings. The primary outcome was complete healing at 16 weeks, stratified by factors such as glycated hemoglobin (HbA1c), BMI, Wagner severity, ulcer location, size, and duration.
Improved Healing Rates with ON101
In the pooled study population, ON101 showed a significantly higher complete healing rate compared to the control group (61.7% vs 37.0%; OR, 2.75; 95% CI, 1.68-4.50; P = .0001). Furthermore, ON101 was associated with a higher probability of complete healing (HR, 1.82; 95% CI, 1.28-2.57; P = .001). The median time to wound closure in the ON101 group was 13.7 weeks, while it could not be determined in the control group due to a lower healing rate (37%).
Subgroup Analysis Highlights Benefits
Subgroup analyses revealed that ON101 was associated with higher odds of achieving complete healing compared to conventional dressings across various risk factors:
- Lower and higher HbA1C levels
- Lower and higher BMI
- Wagner grade 1 and 2 severity
- Nonplantar and plantar ulcers
- Smaller and larger ulcers
- Shorter and longer ulcer durations
Notably, the time to wound closure was significantly shortened with ON101 in patients with similar risk factors. For instance, patients with higher BMI (HR, 2.49; P < .001) and Wagner grade 2 severity (HR, 2.05; P < .001) experienced faster healing with ON101.
Expert Commentary
According to the study authors, "We observed robust healing effectiveness of ON101 for severe ulcers with risk factors classified as ulcer severity, depth, size, duration, and location or in patients with systemic risk factors such as high HbA1c level and BMI."
Study Limitations
The authors noted a key limitation of this study is its post-hoc design, which did not control for the type I error rate.
Funding and Disclosures
This research was supported by Oneness Biotech Company Limited, Microbio Company Limited, and Haihe Biopharma Company Limited. Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies.
