Publications library Research article
CWCMR · 2026
Nakayama, B., Liden, B.A., Griffey, K., Tramelli, B., & Serena, T.E.
Journal of Chronic Wound Care Management and Research (CWCMR)
This retrospective study compared 20 diabetic foot ulcers in 19 US patients treated with ON101, a topical wound-bed matrix, plus standard wound care against 40 ulcers from a historical standard-of-care group. By week 12, 55.0% of the ON101-treated ulcers had closed completely compared with 12.5% in the historical group (p=0.0012), and closures happened earlier with ON101. Wound area reduction at week 4 also favored ON101, but could only be measured in half of the ON101-treated ulcers. Because the comparison group was not treated at the same time and the groups differed at baseline, the authors call the findings exploratory and in need of confirmation in prospective controlled studies. The study was funded by Oneness Biotech, the manufacturer of ON101.
Four of the five authors are SerenaGroup researchers, including Dr. Thomas Serena. SerenaGroup was paid by Oneness Biotech for medical writing support on the manuscript.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
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