Bridging regenerative biology to wound healing: A prospective, multicenter clinical trial of a dehydrated trilayer amniotic tissue for the treatment of chronic lower extremity diabetic foot ulcers
DOI:
https://doi.org/10.63676/14pdez05Keywords:
Amnion-chorion-amnion, angiogenesis, chronic wound, DFU, extracellular matrix, growth factors, healing, lower extremity ulcersAbstract
Aims: Lower extremity chronic diabetic foot ulcers (DFUs) continue to be among the most common cause of long term disability and amputation. Historically, with standard of care (SOC) an average healing rate of only 24.2% is achieved. This prospective, multicenter, single arm trial (NCT07219004) assessed the efficacy of the dehydrated trilayer human amniotic tissue graft, Artacent AC® (Q4190) on nonhealing DFUs.
Methods: A total of 37 participants were recruited in five wound care centers in the United States and from these, 11 patients treated with Artacent AC were analyzed.
Results: Six out of 11 ulcers (55%) completely healed after 12 weeks, with a mean healing duration of 8.8 weeks. The remainder of the wounds experienced sustained improvement with a mean reduction in ulcer area of 68%, 80%, and 84% at weeks 4, 8 and 12, respectively.
Conclusion: These data exceed historic outcomes for patients treated only with SOC and justifies the application of multilayer amniotic tissue grafts, which deliver extracellular matrix architecture, cytokines and growth factor to regulate inflammation, induce angiogenesis, and promote epithelial repair. These findings support the use of Artacent AC as an adjunctive treatment in order to hasten the healing of diabetic foot ulcers. Larger randomized controlled studies are needed to confirm these findings.
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Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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