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 BioREtain® Amniotic Membrane (BR-AM) in conjunction with standard care versus standard care alone for treating diabetic foot ulcers. This research is significant as it could offer a more effective treatment option for patients with non-healing diabetic foot ulcers.
The intervention being tested is BR-AM, a single-layer amniotic membrane allograft processed by BioStem Technologies. It is intended to enhance the healing of diabetic foot ulcers when used alongside standard care, which includes debridement, wound cleansing, and appropriate dressings.
The study is designed as a randomized, controlled trial with a parallel intervention model. It employs single masking, where an independent reviewer assesses wound closure to minimize bias. The primary purpose of the study is treatment-focused.
The study began on October 28, 2024, with its primary completion and estimated completion dates yet to be announced. The last update was submitted on July 21, 2025, indicating ongoing progress in the trial.
This study update could positively impact BioStem Technologies’ stock performance by showcasing potential advancements in diabetic foot ulcer treatment. It may also influence investor sentiment favorably, especially if the results demonstrate significant efficacy compared to standard care alone. Competitors in the wound care industry will likely monitor these developments closely.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.