A new topical treatment for foot ulcers — targeted toward people with diabetes — has been shown to be far more effective than absorbent dressings to help ulcers heal, according to a new study published in the journal JAMA Network Open.
The trial involved a cream called ON101, a formulation containing two different plant extracts that was developed by Oneness Biotech and is already sold in Taiwan (but not the United States) under the brand name Fespixon, as noted in a Medscape article on the study. This treatment works by regulating macrophages — specialized white blood cells that promote wound healing by detecting and destroying bacteria, as well as helping to remove dead tissue. It is believed that in many people with diabetes, macrophages don’t work as they should, which contributes to inadequate healing when someone develops a wound such as a foot ulcer.
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Promising trial results
The latest trial involved 236 people with diabetic foot ulcers, who were randomly assigned to one of two treatment groups. The average age of participants was 57, and their average A1C level (a measure of long-term blood glucose control) was 8.1%, indicating less than ideal glucose control. The first treatment group received an application of ON101 with gauze immediately after debridement of their ulcer (removal of dead or damaged tissue), and the second group had an absorbent dressing applied — a common treatment to help foot ulcers heal. The study took place at 21 different health care provider locations in the United States, Taiwan, and mainland China. The ON101 group applied the treatment twice daily, while the absorbent dressing group changed their dressing once daily or two to three times a week, for a total of 16 weeks — or a shorter period, if the ulcer healed before 16 weeks. The study also included an additional 12-week follow-up period.
Within the ON101 group, 60.7% had their foot ulcer heal completely within the 16-week study period. But in the group that applied absorbent dressings, only 35.1% had their ulcer heal within this timeframe. The ON101 group experienced adverse events (such as a reaction to the cream) in 5.7% of participants, while the absorbent-dressing group experiences adverse events in 4.4% of participants. There were no treatment-related serious adverse events in the ON101 group, while one person in the absorbent-dressing group (0.9% of the group) had a serious reaction.
The researchers concluded that ON101 “exhibited better healing efficacy than absorbent dressing alone” for treating diabetic foot ulcers, and “showed consistent efficacy among all patients,” including those with risk factors that tend to be associated with poor wound healing — such as an A1C level of 9% or higher, or an ulcer size greater than 5 square centimeters (0.78 square inches).
Oneness Biotech expects to complete a second clinical trial of ON101 in the United States in 2023, and to file a new drug application with the U.S. Food and Drug Administration (FDA) as soon as those results are available. A global launch of the product is expected in 2025.