A new macrophage-regulating topical cream is more effective at treating diabetic foot ulcer than an absorbent dressing alone, according to a new phase-3 trial.

The study "has shown that the macrophage-regulating new drug, ON101, is clinically superior to the current standard care. We recommended to physicians to use it right after debridement as the standard care to avoid the risk of infection and amputation," the study's corresponding author, Dr. Shun-Cheng Chang of Taipei Medical University-Shuang Ho Hospital, in New Taipei City, Taiwan, told Reuters Health by email.

The cream was recently approved by the Taiwan Food and Drug Administration and is marketed there under the brand name Fespixon by Oneness Biotech, which paid for the study with two other companies.

Dr. Chang and colleagues randomized 236 patients in 21 medical centers in the United States, China and Taiwan to twice-daily ON101 dressings for up to 16 weeks or absorbent dressings (Hydrofiber, ConvaTec) in the control group.

Evaluators were blinded to treatment.

More than three-quarters of the participants had grade-2 ulcers on the Wagner system of one to five, in which one is superficial and five is extensive gangrene. The rest had grade 1.

Included ulcers had a mean area of 4.8 cm2 and a mean duration of 7.2 months at the start of the study. Mean hemoglobin (Hb)A1c level was 8.1% at baseline, and 27% of the participants had baseline HbA1c levels of at least 9%.

Nearly twice the number of patients in the treatment group completely healed compared to the control group (61% vs. 35%, P<0.001).

The odds ratio of complete healing was 2.84 (P<0.001) with ON101 versus the absorbent dressing alone. No serious adverse events were reported in the treatment group, while one occurred in the control group.

An intention-to-treat analysis that excluded patients with ulcers that did not meet the study's inclusion criteria at baseline found similar results.

"Early use will definitely bring greater benefits to the patients because ON101 can reach faster healing. Furthermore, ON101 can be topically self-administered by the patients at home and such easiness of use will increase patients' compliance," Dr. Chang said.

Oneness Biotech has started another phase-3 trial of the product in the U.S. Dr. Chang reports financial ties to the company.

SOURCE: https://bit.ly/3FbcmOv JAMA Network Open, online September 3, 2021.