FORT WORTH, Texas, May 20, 2026 /PRNewswire/ -- Legacy Medical Consultants, a leading provider of allografts for the treatment of hard-to-heal chronic wounds, today announced the initiation of the REBOUND clinical trial: a prospective, post-market randomized controlled study evaluating Orion™, a dual-layer amniotic membrane allograft for the management of diabetic foot ulcers (DFUs) in adults ages 50 to 85 years old.
The study, formally titled "A Prospective, Post-market Randomized Controlled Trial (RCT) to Demonstrate Clinical Utility of an Amniotic Membrane Allograft in Diabetic Foot Ulcer (DFU) Wound Management," is registered as NCT06420245 on ClinicalTrials.gov.
"Amniotic tissue therapies represent an important step toward achieving healing that is both meaningful and durable" said Cyyandi Dove, DPM, Principal Investigator and podiatric surgeon at Oregon Health & Science University.
Legacy Medical Consultants is partnering with a network of leading wound care and research centers across the United States to conduct the trial. ILD Research Center in Vista, California, led by Dean Vayser, DPM, is the first site to begin enrollment.
"Despite meaningful advances in wound care, too many diabetic patients with chronic ulcers fail to heal and progress to develop an infection, hospitalization, and even limb loss," Vayser said. "We see the urgent need for therapies that can help us not only close wounds faster and more reliably but also prevent recurrence. We are excited to participate in the REBOUND trial to generate high-quality evidence that can directly inform how clinicians care for diabetic foot ulcers."
REBOUND is a randomized, parallel assignment interventional trial enrolling an estimated 240 participants to receive either standard of care (SOC) alone, or SOC plus weekly application of the Orion™ amniotic membrane allograft. The primary endpoint is the percentage of enrolled study participants demonstrating 100% re-epithelialization of the index wound without leaking exudate at 12 weeks post-randomization. Secondary endpoints include time to wound closure, quality of life outcomes, recurrence within six months, wound size change, product utilization, and safety events.
Orion™ is a sterile, dual-layer amniotic membrane allograft made from dehydrated extracellular matrix, designed to provide a protective wound covering and support tissue ingrowth, encouraging angiogenesis, and limiting microbial spread. Amniotic allograft membranes used in this study are confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act, as defined in 21 CFR Part 1271 for DFU management.
The REBOUND trial began enrollment on December 30, 2025, with estimated primary completion in November 2026 and overall study completion in July 2027.
For more information, clinicians and potential participants can search NCT06420245 on ClinicalTrials.gov and contact the study team using the publicly listed details.
About Legacy Medical Consultants
Legacy Medical Consultants (LMC) elevates patient care by addressing unmet clinical needs in patients with wounds. LMC's team of dedicated professionals serves both providers and their patients in the field of complex wound care. To learn more about LMC's portfolio of products please visit https://www.legacymedicalconsultants.com/.
View original content:https://www.prnewswire.com/news-releases/legacy-medical-consultants-announces-initiation-of-rebound-clinical-trial-evaluating-orion-amniotic-membrane-allograft-for-diabetic-foot-ulcers-302776989.html
SOURCE Legacy Medical Consultants
