Groundbreaking study aims to improve healing outcomes and reduce complications for patients with chronic wounds. The study will also reduce the number of patients being randomized into control groups by utilizing historic controls data documented in similar wound healing studies (matched controls). This will reduce the overall number of patients needed to complete trials, allowing products that show positive clinical value to get to patients sooner.
San Antonio, TX — July 9, 2025 — Sequence LifeScience, Inc., a leader in allograft tissue processing, today announced that in collaboration with SerenaGroups Inc., have received Institutional Review Board (IRB) approval to initiate a new clinical trial evaluating the effectiveness of placental membrane allografts in the treatment of diabetic foot ulcers (DFUs). The trial design is novel in that it employs a matched controls design using historical data to ensure robust, comparative data on treatment efficacy and safety.
Diabetic foot ulcers are 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.
This new clinical trial seeks to address that gap through a rigorously designed, controlled investigation of placental membrane products produced by Sequence LifeScience, Inc.
Trial Overview:
• Study Title: 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
• Study Design: Master trial design: Prospective Modified Platform Multicenter Matched Controls Clinical Trial
• Primary Endpoint: Rate of complete wound healing at 12 weeks
• Secondary Endpoints: Time to closure over 12 weeks, percent area reduction in wound size at weekly intervals, reduction in adverse events, improvement in quality of life
• Enrollment Target: Over 300 participants at up to 30 clinical sites in the U.S.
• Eligibility: Adults diagnosed with DFUs meeting specific inclusion/exclusion criteria.
“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. “By using a Matched Controls, Modified Platform Trial, we can generate high-quality data that will advance the field and inform clinical best practices,” said Dr Thomas Serena, Founder and CEO SerenaGroup Inc. and lead investigator for the study.
Patient recruitment is expected to begin in July, 2025, with results anticipated third quarter 2026. This 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.
For more information about the clinical trial or participation opportunities, please visit https://nvisionbiomed.com/
Media Contact:
Stephanie Lopez
StephanieLopez@fountainheadbh.com
210-545-3713
4590 Lockhill Selma Rd.
San Antonio, TX 78249
