Effects of ON101 for Hard-to-Heal Diabetic Foot Ulcers in a Randomized Phase III Trial: A Analysis.
Journal
Advances in wound care
ISSN
2162-1918
Date Issued
2024-09-05
Author(s)
Chang, Shun-Cheng
Lin, Ching-Wen
Chen, Jui-Ching
Wu, Yi-Hsin
Chen, Shyi-Gen
Huang, Yu-Yao
Cazzell, Shawn M
Chen, Hsin-Han
Huang, Kuo-Feng
Tung, Kwang-Yi
Huang, Hsuan-Li
Perng, Cherng-Kang
Shi, Bimin
Liu, Chang
Ma, Yujin
Cao, Yemin
Li, Yanbing
Xue, Yaoming
Gao, Fang
Cao, Ying
Yan, Li
Li, Qiu
Armstrong, David G
Ning, Guang
Abstract
Hard-to-heal diabetic foot ulcers (DFUs) are associated with higher mortality rates and an increased medical burden for patients. ON101, a new topical cream, exhibited better healing efficacy than the control dressing in a Phase III trial. In this analysis, we further identify whether ON101 can improve the healing of ulcers with hard-to-heal risk factors in this cohort of DFU patients. To compare the efficacy of ON101 with absorbent dressing among various hard-to-heal wounds in patients with DFU, a analysis of a randomized Phase III trial that included 276 DFU patients was performed by subgrouping those patients based on ulcer depth, location, size, duration, and patients' glycated hemoglobin (HbA1c) levels and body mass index (BMI). In the full analysis set, the proportion of patients achieving healing was 61.7% in the ON101 group and 37.0% in the comparator ( = 0.0001). In subgroup analysis according to risk factors, ON101 demonstrated superior healing capacity on Wagner grade 2 ulcers ( < 0.0001); plantar ulcers ( = 0.0016), ulcer size ≥5 cm ( = 0.0122), ulcer duration ≥3 months ( = 0.0043); for patients with HbA1c ≥9% ( = 0.0285); and patients with BMI ≥25 ( = 0.0005). ON101, a novel therapeutic drug, can modulate the functions of macrophages and demonstrate superior healing rates to conventional absorbent dressing in patients with hard-to-heal DFUs. The results of this study suggest that ON101 is a better therapeutic option than conventional dressing used in treatment for DFU patients with higher HbA1c, BMI, or ulcers with complex conditions such as longer duration, deeper wounds, larger size, and plantar location.
Subjects
BMI
DFU
HbA1c
diabetic foot ulcer
hard-to-heal
plantar
ulcer depth
ulcer duration
ulcer size
SDGs
Type
journal article