BioStem Technologies, Inc. (OTC: BSEM) has announced the initiation of the BR-AC-DFU-101 clinical trial, designed to evaluate the efficacy of BR-AC (BioREtain – Amnion Chorion) in treating non-healing diabetic foot ulcers (DFUs). This strategic study aims to demonstrate the potential superiority of BR-AC over the standard of care, which could lead to increased insurance coverage and market growth.
The BR-AC-DFU-101 trial will focus on patients with DFUs who have adequate perfusion but show no clinical signs of infection. The study plans to enroll 60 patients across ten sites in the United States, with an anticipated completion date by the end of 2025. Participants will undergo weekly visits to monitor wound care compliance, off-loading, and to document wound closure progress.
Trial Design and Objectives
The primary outcome of the BR-AC-DFU-101 study is to determine whether the addition of BR-AC to standard care results in a higher probability of complete wound closure compared to standard care alone within a 12-week period. Secondary outcome measures include:
- Comparing the differences between treatment groups in the proportions of wounds achieving complete closure.
- Assessing the time in days to complete wound closure over 12 weeks.
- Evaluating the percent change in wound area (cm²) and volume (cm³).
- Determining the total number of BR-AC applications required for complete wound closure.
Jason Matuszewski, CEO of BioStem Technologies, stated, “We are excited to initiate the BR-AC-DFU-101 clinical trial, which aims to potentially demonstrate the clinical significance of our proprietary BioREtain technology against the standard of care... Ultimately, we aim to better address the needs of patients suffering from non-healing diabetic foot ulcers and improve their quality of life.”
Diabetic Foot Ulcers: A Significant Health Challenge
Diabetic foot ulcers represent a serious and chronic condition affecting a substantial portion of the diabetic population. According to the American Podiatric Medical Association (APMA), approximately 15% of individuals with diabetes will develop foot ulcers. A concerning 6% of these individuals may require hospitalization due to infections or other ulcer-related complications. DFUs are the primary cause of lower extremity amputations in the U.S., with studies indicating that 14% to 24% of diabetic individuals with foot ulcers may ultimately require amputation.
Recent data analysis from GlobalData Plc. indicates that 2.2 million patients received treatment for DFUs in 2023, and these numbers are projected to increase. The economic impact of DFUs on healthcare systems is considerable, with annual treatment costs estimated between $9 billion and $13 billion in the United States alone.
About BioREtain Technology
BioStem’s allografts are processed using the company’s patented BioREtain® method, which focuses on preserving the tissue’s endogenous biological properties while maintaining the structure and matrix found in fresh perinatal tissue. The six-step BioREtain® process is designed to be gentle and minimally invasive, preserving the natural integrity of the amniotic tissue components critical to the inherent wound-healing process.
