How effective is a new macrophage-regulating drug for wound healing in patients with diabetic foot ulcers?

This study compared the therapeutic benefit of topically applied ON101 (Fespixon) cream to an absorbent dressing (Hydrofiber; ConvaTec Ltd) on wound healing in patients with chronic diabetic foot ulcers (DFUs). The authors concluded that the therapeutic effectiveness of ON101 treatment of DFUs was better compared to absorbent dressing.

DFUs are open sores or wounds on the feet of patients with diabetes. High blood glucose may affect a white blood cell type called a macrophage. It also affects the blood supply to the foot and the ability to feel pain due to nerve damage. Delayed healing of DFUs can result in hospitalizations and amputations (surgical removal of limbs). Despite the use of current therapies, amputations have increased annually. There is a need to explore new, potentially more effective treatments for DFUs.

ON101 is a locally applied medication made of a cream base and a proprietary formulation of two medicinal plant extracts. PA-F4 is an extract of Plectranthus amboinicus while S1 is an extract of Centella asiatica. Preliminary evidence suggests that these extracts can affect the balance between two types of macrophages, M1 and M2. M1 macrophages are involved in inflammation. M2 macrophages are important for collagen production, tissue repair, and wound healing. It is not known if ON101 cream is more effective for DFU healing compared to an absorbent dressing. 

This study included 236 patients with DFUs for more than 4 weeks. Patients were randomly allocated to two groups. 122 patients received twice-daily applications of ON101 and 114 patients had an absorbent dressing that was changed once daily or 2 to 3 times weekly, for 16 weeks. The follow-up period was 12 weeks. 

74 (50.7%) patients in the ON101 group had complete healing (ulcer closure), compared to 40 (35.1%) patients in the absorbent dressing group, within 16 weeks.

7 (5.7%) patients in the ON101 group, and 5 (4.4%) patients from the absorbent dressing group, had side effects that were not present before treatment. None of these side effects were considered related to the ON101 treatment. 

The study suggested that treatment with ON101 had better therapeutic effectiveness than absorbent dressing in patients with DFUs.

The study design allowed patients and investigators to know the treatment groups allocations. Patients that needed dialysis were not accounted for in the study. The study only included Asian patients. Further studies are needed in other ethnic groups. This study was funded by the manufacturer of ON101.