#United States #Fort Worth #Diabetic Foot Ulcer #Orion™ #Legacy Medical Consultants

Legacy Medical Consultants Launches REBOUND Clinical Trial

Legacy Medical Consultants, a prominent name in the field of allografts aimed at treating chronic wounds, has officially announced the launch of a groundbreaking clinical trial known as the REBOUND trial. This prospective, post-market randomized controlled trial seeks to evaluate the efficacy of the Orion™ amniotic membrane allograft specifically for managing diabetic foot ulcers (DFUs) in adults aged between 50 to 85 years.

The study, formally registered as NCT06420245 on ClinicalTrials.gov, aims to demonstrate the clinical benefits of utilizing amniotic tissue therapies, which are anticipated to significantly enhance the healing process for patients suffering from these stubborn and often debilitating conditions.

Dr. Cyyandi Dove, a principal investigator and podiatric surgeon from Oregon Health & Science University, expressed the importance of amniotic tissue therapies: "These therapies represent a crucial advancement toward achieving both meaningful and durable healing outcomes for patients with chronic wounds."

Partnership with Leading Wound Care Centers

To conduct the REBOUND trial, Legacy Medical Consultants is collaborating with a network of top-notch wound care and research facilities across the United States. The first site to kickstart participant enrollment is the ILD Research Center, based in Vista, California, under the guidance of Dr. Dean Vayser.

Dr. Vayser acknowledged the pressing need for innovative treatments by stating, "Despite our advancements in wound care, many diabetic patients with chronic ulcers struggle to heal, often facing severe complications such as infections, hospitalizations, and even limb loss. We recognize the urgent requirement for therapies capable of not only closing wounds effectively but also preventing their recurrence. The REBOUND trial promises to generate high-quality evidence that can directly inform clinical practices for diabetic foot ulcer management."

Trial Design and Objectives

The REBOUND trial is devised as a randomized, parallel assignment interventional study intending to enroll around 240 participants. These participants will be divided into two groups: one receiving the standard of care (SOC) alone, while the other will apply the Orion™ amniotic membrane allograft weekly in addition to SOC.

The primary goal of the trial is to assess the percentage of participants achieving complete re-epithelialization of their wounds without any exudate leakage at the 12-week mark following randomization. Secondary objectives encompass time to wound closure, improvements in quality of life, analysis of recurrence rates within six months, changes in wound size, assessment of product utilization, and monitoring for safety events.

Designed as a sterile, dual-layer amniotic membrane allograft, Orion™ aims to provide a protective cover for wounds while fostering tissue ingrowth, encouraging angiogenesis, and limiting the spread of infection. This innovative product has received FDA clearance and meets all necessary regulations for DFU management under the PHS Act.

Timeline and Future Directions

The enrollment for the REBOUND trial officially began on December 30, 2025, with the primary completion anticipated in November 2026 and overall study completion expected by July 2027. Interested clinicians and potential participants are encouraged to search for NCT06420245 on ClinicalTrials.gov for additional information and to contact the study team through the provided public details.

About Legacy Medical Consultants

Legacy Medical Consultants (LMC) is dedicated to enhancing patient care by addressing unmet needs in chronic wound management. The expert team at LMC is committed to supporting both healthcare providers and their patients through innovative solutions in complex wound care. To explore LMC's array of products, visit Legacy Medical Consultants.