Clinical Trial: Artacent Amniotic Tissue for Chronic Lower Extremity Diabetic Ulcers
Summary: Sponsored by Tides Medical, this completed interventional Phase 2 trial (NCT07219004, started March 3, 2023) investigates the efficacy of Artacent—a tri-layered dehydrated human amnion/chorion/amnion composite graft—as a treatment for chronic lower extremity diabetic ulcers persisting despite standard care. Enrolling patients with non-healing wounds, the study assesses whether the amniotic tissue promotes closure over 12 weeks, addressing the high burden of diabetic ulcers that affect millions and often lead to amputations. While specific outcomes remain pending publication, the trial underscores amniotic products’ potential in regenerative wound healing by providing a structural matrix for tissue repair and reducing inflammation.
Key Highlights:
- Trial design: Interventional, single-group assignment; focuses on 12-week healing in chronic diabetic lower extremity ulcers.
- Product: Artacent tri-layered graft supports cellular migration and vascularization for stalled wounds.
- Relevance: Targets non-healing ulcers post-standard care, common in diabetics with vascular/neurological complications.
- Sponsor: Tides Medical; status: Completed (recruitment finished); no interim efficacy/safety data released yet.
- Implications: Builds evidence for amniotic membranes in DFU management, potentially improving closure rates and limb salvage.
Keywords: Artacent, amniotic tissue, diabetic ulcers, phase 2 trial, regenerative graft