Sequence LifeScience, Inc., a leader in allograft tissue processing, announced that in collaboration with SerenaGroups Inc., they have received Institutional Review Board (IRB) approval to initiate a clinical trial evaluating placental membrane allografts for treating diabetic foot ulcers (DFUs). The trial employs an innovative matched controls design using historical data to ensure robust comparative data on treatment efficacy and safety.
Novel Trial Design Addresses Clinical Challenges
The study represents a groundbreaking approach to chronic wound research by leveraging past data to reduce control groups and improve healing outcomes. According to the companies, this design will reduce the number of patients randomized into control groups by utilizing historic controls data documented in similar wound healing studies. This approach will decrease the overall number of patients needed to complete trials, allowing products that show positive clinical value to reach patients sooner.
Diabetic foot ulcers represent a serious and growing complication of diabetes, leading to prolonged hospitalizations, increased risk of infection, and in severe cases, amputation. Despite advancements in wound care, healing rates remain suboptimal for many patients, creating a significant unmet medical need that this trial aims to address.
Trial Specifications and Endpoints
The multicenter study, titled "A Multicenter, Prospective, Matched Controls, Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls," will follow a prospective modified platform multicenter matched controls clinical trial design.
The primary endpoint focuses on the rate of complete wound healing at 12 weeks. Secondary endpoints include time to closure over 12 weeks, percent area reduction in wound size at weekly intervals, reduction in adverse events, and improvement in quality of life. The trial targets enrollment of over 300 participants across up to 30 clinical sites in the United States, with eligibility limited to adults diagnosed with DFUs meeting specific inclusion and exclusion criteria.
Industry Leadership and Clinical Impact
"This IRB approval represents a critical milestone in our efforts to bring innovative, evidence-based solutions to patients suffering from chronic wounds," said Brian Kieser, CEO of Sequence LifeScience. Dr. Thomas Serena, Founder and CEO of SerenaGroup Inc. and lead investigator for the study, emphasized the methodological advantages: "By using a Matched Controls, Modified Platform Trial, we can generate high-quality data that will advance the field and inform clinical best practices."
Timeline and Future Outlook
Patient recruitment is expected to begin in July 2025, with results anticipated in the third quarter of 2026. The study aligns with Sequence LifeScience's broader mission to provide products with real clinical value to patients and physicians through cutting-edge research and compassionate care. This timeline positions the trial to potentially provide crucial data on placental membrane allografts' effectiveness in addressing the persistent challenge of diabetic foot ulcer healing.
