Diabetic foot ulcers can be really nasty things. When they get out of control, they can lead to the gangrene-like condition called necrosis, in which body tissues die. The possible result: amputation. About 80% of lower-limb amputations in people with diabetes take place after the patient experiences chronic foot ulcers.
There are several treatments, and their rates of success vary. Among them are debridement (removing dead skin and tissue), offloading (removing weight and pressure from the wound, such as through the use of crutches), special dressings, surgery, and treatment in a hyperbaric oxygen chamber.
New cream shows dramatic healing effects
Now, according to a report just published online in JAMA Network Open, a new topical cream has been shown to be dramatically effective in treating diabetic foot ulcers. The research team, which was headed by Yu-Yao Huang, MD, of Chang Gung Memorial Hospital in Taoyuan City, Taiwan, treated 236 diabetes patients with foot ulcers for 16 weeks (with a 12-week follow-up). The patients had an average age of 57 and three out of four were men. A group of 122 were treated with the new topical cream twice a day, while 114 other patients were given an absorbent dressing containing sodium carboxymethylcellulose that was changed twice a day. After the treatment period, it was determined that 60%of those in the topical cream group experienced “complete healing,” while the healing rate among the absorbent dressing patients was 35%.
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The topical cream, called ON101, combines two active ingredients. One, PA-F4, comes from an extract of Plectranthus amboinicus, a perennial herb that grows in warm climates and has been shown to have therapeutic and nutritional properties. The second, S1, is obtained from an extract of Centella asiatica, a herb from East Asia that has been shown to be beneficial in wound healing, the treatment of skin conditions (lupus, eczema, and psoriasis, for example), as well as in other problems, such as diarrhea, fever, and anxiety.
Both substances have also been shown to regulate the activity of macrophages, which are types of white blood cells that kill microorganisms, remove dead cells, and stimulate other cells in the immune system. They’ve been shown to play a vital role in tissue repair and in the regulation of the healing process, and, according to the authors of the new study, “accumulating scientific evidence has revealed that targeting macrophage phenotypes might be a potentially effective therapy” in diabetic foot ulcers. Although high blood sugar increases the ratio in foot ulcers of inflammation-causing M1 macrophages to regenerative M2 macrophages, ON101 helps regulate the balance between M1 and M2 macrophages.
The authors summed up their findings by writing, “Topical application of ON101 with gauze immediately after debridement demonstrated significant healing efficacy compared with an absorbent dressing in all patients, including those with DFU [diabetic foot ulcer]-related risk factors. To our knowledge, this study is the first international phase III randomized clinical trial of an investigational drug able to regulate M1/M2 macrophage activities in patients with DFUs.”
ON101 is manufactured by a Taiwanese firm called Oneness Biotech and marketed under the trade name Fespixon. It has been available in Taiwan since June, and in the United States the U.S. Food & Drug Administration (FDA) has granted ON101 a Fast Track Designation to speed its development. To that end, diabetic foot ulcer patients are participating in a currently recruiting clinical trial. In addition, Oneness Biotech has initiated an expanded access program under FDA regulation that will allow foot ulcer patients in the United States to obtain the medication in the pre-approval or clinical stage. Information can be found at the company website.
Study author Shun-Cheng Chang, MD, told Diabetes Self-Management, “It is anticipated that the new drug will be commercially available in 2024 as Oneness Biotech is currently in negotiation with global companies on commercialization collaboration. We also hope it can be available in the U.S. soon so that more patients can be benefited by the novel treatment earlier. The supply capacity can be up to 25 million tubes per year.” ON101 is also being studied for possible use in such conditions as venous leg ulcers, pressure ulcers, radiology dermatitis, surgical scar removal, and burn wounds.
Want to learn more about foot ulcers? Read “Diabetic Foot Ulcers: What They Are and How You Can Avoid Them?”