BioStem Technologies ((BSEM)) announced an update on their ongoing clinical study.
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BioStem Technologies is conducting a clinical study titled A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM. The study aims to evaluate the safety and efficacy of the BioREtain® Amniotic Membrane (BR-AM) in conjunction with standard care compared to standard care alone for treating diabetic foot ulcers. This research is significant as it could offer a new treatment option for a challenging condition.
The intervention being tested is BR-AM, a single-layer amniotic membrane allograft processed by BioStem Technologies. It is intended to enhance healing when applied to diabetic foot ulcers, potentially improving outcomes over standard care alone.
The study is designed as a randomized, controlled trial with a parallel intervention model. It uses single masking, where an independent reviewer assesses wound closure to minimize bias. The primary purpose is treatment-focused, aiming to determine the effectiveness of BR-AM in healing ulcers.
Key dates for the study include its start date on August 19, 2024, and the last update on August 25, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.
The market implications of this study are significant for BioStem Technologies, as positive results could enhance their stock performance and attract investor interest. The study’s outcomes could also influence the competitive landscape in the diabetic wound care industry, potentially setting a new standard for treatment.
The study is currently ongoing, with further details available on the ClinicalTrials portal.