BioStem Launches BR-AM-DFU Clinical Trial for Non-Healing Diabetic Foot Ulcers

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Today, BioStem Technologies announced the launch of the BR-AM-DFU (BioREtain® Amniotic Membrane - Diabetic Foot Ulcers) clinical trial, which will evaluate the use of Vendaje® in treating patients with non-healing diabetic foot ulcers.¹ The novel study will evaluate the standard of care treatment with and without Vendaje, aiming to demonstrate its superiority in advanced wound care.

“We are committed to advancing clinical trials that benchmark our products against the standard of care,” Jason Matuszewski, CEO of BioStem, said in a statement. “Vendaje is an innovative wound care option for patients with chronic, non-healing wounds, and this trial represents a key milestone in showcasing our BioREtain technology within the diabetic foot ulcer market. As we continue to onboard patients for the trial, we look forward to sharing updates on key clinical milestones.”¹

This minimally invasive BioREtain technology involves placental allografts, which preserve the endogenous biological properties of the tissue. It also ensures that the structure and matrix found in the fresh perinatal tissue are maintained. Although Vendaje is already commercially available, the trial hopes to further confirm its clinical effectiveness in preserving the integrity of amniotic tissue while increasing the product’s market adoption.

The BR-AM-DFU trial (NCT06565156) is a multicenter, randomized, controlled study that will take place across 12 sites in the United States. Approximately 60 participants with non-healing diabetic foot ulcers will be enrolled. This population will have adequate perfusion and no clinical signs of infection. 

Patient evaluations will occur every week for 12 weeks to monitor compliance and assess the number of participants who achieve full wound closure, which is defined as 100% re-epithelialization. There will also be a 4-week follow-up phase for patients who reach complete wound closure to measure the longevity and durability of the treated area.

This is the second active BioStem Technologies clinical trial related to diabetic foot ulcers. A similar prospective study, BR-AC-DFU-101 (BioREtain® – Amnion Chorion – Diabetic Foot Ulcers), began in October 2024 and is observing the effectiveness of the AmnioWrap2™ placental tissue for patients with diabetic foot ulcers.² Both trials are looking to be completed by the end of this year.

“Our patented BioREtain process is the technology utilized in our products and will be a key differentiator for BioStem’s commercial products going forward. Ultimately, we aim to better address the needs of patients suffering from non-healing diabetic foot ulcers and improve their quality of life,” Matuszewski said in a press release. “We are confident that the results will highlight the strength of our technology and provide substantial benefits to support BioStem and its shareholders as the company advances.”²

References

1. BioStem Technologies Launches Clinical Trial to Demonstrate the Therapeutic Benefits of its BioREtain® Technology in Treating Diabetic Foot Ulcers Using Vendaje®. News release. Globe Newswire. January 8, 2025. Accessed January 8, 2025. https://www.globenewswire.com/news-release/2025/01/08/3006089/0/en/BioStem-Technologies-Launches-Clinical-Trial-to-Demonstrate-the-Therapeutic-Benefits-of-its-BioREtain-Technology-in-Treating-Diabetic-Foot-Ulcers-Using-Vendaje.html

2. BioStem Technologies Initiates BR-AC-DFU-101 Clinical Trial to Study BioREtain® in Diabetic Foot Ulcers. News release. Globe Newswire. October 2, 2024. Accessed January 8, 2025. https://www.globenewswire.com/news-release/2024/10/02/2956815/0/en/BioStem-Technologies-Initiates-BR-AC-DFU-101-Clinical-Trial-to-Study-BioREtain-in-Diabetic-Foot-Ulcers.html