BioStem’s Innovative Approach to Diabetic Foot Ulcers: A Clinical Study Update

BioStem Technologies ((BSEM)) announced an update on their ongoing clinical study.

BioStem Technologies is conducting a significant clinical study titled ‘A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC.’ The study aims to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) in combination with standard care versus standard care alone for treating diabetic foot ulcers. This research is crucial as it addresses the challenge of non-healing diabetic foot ulcers, which often require advanced therapies beyond standard care.

The intervention being tested is BR-AC, a human placental allograft designed to enhance healing in diabetic foot ulcers. It is applied directly to the wound surface, aiming to increase the rate of complete healing within 12 weeks compared to standard care alone.

The study is interventional with a randomized, parallel assignment model. It employs single masking, where an independent reviewer assesses wound closure to reduce bias. The primary purpose of the study is treatment-focused, aiming to improve healing outcomes for patients.

The study began on September 3, 2024, with its primary completion and estimated overall completion dates yet to be announced. The last update was submitted on June 23, 2025, indicating ongoing progress and data collection.

This study update could positively impact BioStem Technologies’ stock performance by showcasing potential advancements in diabetic foot ulcer treatment, a significant market need. Investors may view this as a promising development, especially if the study results demonstrate superior efficacy of BR-AC compared to standard care. This could also influence competitor strategies within the wound care industry.

The study is currently active but not recruiting, with further details available on the ClinicalTrials portal.