Significantly better healing with ON101 than standard care
For the current phase 3, randomized clinical trial, researchers enrolled patients in 21 clinics from November 2012 to May 2020.
To be eligible for the study, patients had to be 20-80 years old, with a hemoglobin A1c less than 12%. They also had to have a Wagner grade 1 or 2 foot ulcer that was 1-25 cm2 after debridement, had been treated with standard care, and was present for at least 4 weeks.
Patients were a mean age of 57 years and 74% were men. They had a mean A1c of 8.1%, and 61% had had diabetes for more than 10 years.
Most (78%) of the diabetic foot ulcers were Wagner grade 2. The wounds had a mean area of 4.8 cm2 and had been present for a mean of 7 months.
Patients were instructed on how to self-administer ON101 cream twice a day (treatment group, n = 122) or how to apply an absorbent dressing and change it daily or two or three times a week (standard care group, n = 114). All patients were allowed to apply a sterile gauze dressing.
They visited the clinic every 2 weeks during the 16-week treatment phase and 12-week observation phase.
In the full analysis set, 74 patients (61%) in the ON101 group and 40 patients (35%) in the standard care group had complete wound healing after 16 weeks of treatment.
The subgroup of patients at higher risk of poor wound healing (A1c >9%, ulcer area >5 cm2, and diabetic foot ulcer duration >6 months) also had significantly better healing with the ON101 cream than standard care.
There were seven (5.7%) treatment-emergent adverse events in the ON101 group versus five (4.4%) in the standard care group.
There were no treatment-related serious adverse events in the ON101 group versus one (0.9%) in the comparator group.
The study was funded by Oneness Biotech, Microbio Group, and Shanghai Haihe Pharmaceutical. One author has reported receiving fees from Oneness Biotech, and Dr. Chang has reported receiving a speakers fee from Oneness Biotech. The other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.