ON101 is an active wound healing alternative for primary care in patients with chronic diabetic foot ulcers. Taiwan: Topical application of novel macrophage-regulating drug, ON101, was found to improve healing of diabetic foot ulcers (DFUs), according to a recent study in JAMA Network Open.
The study found ON101 to exhibit better healing efficacy than absorbent dressing for DFUs treatment and showed consistent efficacy among all patients.
Dysregulated M1/M2-type macrophages can cause delayed healing of DFUs, and restoring the balance between these macrophage tyoes plays a important role in healing. However, drugs used for M1/M2 macrophages regualtion have not yet been studied in large randomized clinical trials. Considering this, Yu-Yao Huang, Department of Internal Medicine, Chang Gung Memorial Hospital, Taoyuan City, Taiwan, and colleagues compareD the topical application of ON101 cream with use of an absorbent dressing (Hydrofiber; ConvaTec Ltd) when treating DFUs in a multicenter, evaluator-blinded, phase 3 randomized clinical trial performed in 21 clinical and medical centers across the US, China, and Taiwan from November 23, 2012, to May 11, 2020.
The trial included patients with debrided DFUs of 1 to 25 cm2 present for at least 4 weeks and with Wagner grade 1 or 2. They were randomized in the ratio of 1:1 to receive ON101 or control absorbent dressings.
Twice-daily applications of ON101 or a absorbent dressing changed once daily or 2 to 3 times a week for 16 weeks, with a 12-week follow-up.
The primary outcome was the incidence of complete healing defined as complete re-epithelialization at 2 consecutive visits during the treatment period assessed on the full-analysis set (FAS) of all participants with postrandomization data collected.
In the FAS, 236 eligible patients (74.2% men, mean age, 57.0 years; mean glycated hemoglobin level, 8.1%) with DFUs classified as Wagner grade 1 or 2 (mean ulcer area, 4.8 cm2) were randomized to receive either the ON101 cream (n = 122) or the absorbent dressing (n = 114) for as long as 16 weeks.
Key findings of the study include:
- The incidence of complete healing in the FAS included 74
patients (60.7%) in the ON101 group and 40 (35.1%) in the comparator group
during the 16-week treatment period (difference, 25.6 percentage points; odds
- A total of 7 (5.7%) treatment-emergent adverse events occurred
in the ON101 group vs 5 (4.4%) in the comparator group.
- No treatment-related serious adverse events occurred in the
ON101 group vs 1 (0.9%) in the comparator group.
“ON101 exhibited better healing efficacy than absorbent dressing alone in the treatment of DFUs and showed consistent efficacy among all patients, including those with DFU-related risk factors (glycated hemoglobin level, ≥9%; ulcer area, >5 cm2; and DFU duration, ≥6 months),” wrote the authors.
The researchers conclude, “the findings of this study suggest that ON101, a macrophage regulator that behaves differently from moisture-retaining dressings, represents an active-healing alternative for home and primary care of patients with chronic DFUs.”
Huang Y, Lin C, Cheng N, et al. Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2021;4(9):e2122607. doi:10.1001/jamanetworkopen.2021.22607