PRESS RELEASE
Sequence LifeScience, Inc. Receives IRB Approval for a Novel Matched Controls Clinical Trial Targeting Diabetic Foot Ulcers (DFUs)
Groundbreaking study aims to improve healing outcomes and reduce complications for patients with chronic wounds.
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.
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.
TRIAL OVERVIEW
Study at a glance
A multicenter, prospective, modified platform trial across up to 30 U.S. clinical sites.
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: 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
FROM OUR LEADERS
What our team is saying
“This IRB approval represents a critical milestone in our efforts to bring innovative, evidence-based solutions to patients suffering from chronic wounds.”
— Brian Kieser, CEO, Sequence LifeScience, Inc.
“By using a Matched Controls, Modified Platform Trial, we can generate high-quality data that will advance the field and inform clinical best practices.”
— Dr. Thomas Serena, Founder & CEO, SerenaGroup Inc. and Lead Investigator
ENROLLMENT & TIMELINE
Now recruiting
Patient recruitment is expected to begin in July 2025, with results anticipated in the third quarter of 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 contact us directly.
MEDIA CONTACT
Stephanie Lopez
StephanieLopez@fountainheadbh.com
210-545-3713
4590 Lockhill Selma Rd., San Antonio, TX 78249
