Organogenesis Publishes Positive Affinity Trial Results for Venous Leg Ulcers

Organogenesis Holdings Inc. has announced the publication of positive results from a prospective, multicentre, randomized controlled trial evaluating Affinity™ in patients with complex venous leg ulcers (VLUs). Published in the Journal of Wound Care, the peer-reviewed study demonstrated that Affinity plus standard of care (SoC) significantly improved wound closure compared with standard of care alone, providing new clinical evidence for one of the most difficult-to-treat chronic wound populations.

What Is Affinity?

Affinity is the only hypothermically stored human placental allograft composed of fresh, unaltered amniotic membrane that retains its native extracellular matrix scaffold and living cells. Unlike dehydrated or frozen grafts, it is minimally manipulated, aseptically processed, and preserved in a fresh state for use as a protective barrier in the management of acute and chronic wounds.

Randomized Trial Evaluated Long-Standing Venous Leg Ulcers

The study (NCT04901013) enrolled 206 patients across multiple US centers, who were randomized in a 1:1 ratio to receive either Affinity plus standard of care or standard of care alone. Following a four-week run-in period, participants were followed for 24 weeks. The trial included patients with large, chronic venous leg ulcers that had persisted for more than six months or more than 24 months despite conventional treatment, representing a patient population associated with prolonged healing, frequent recurrence, and substantial healthcare costs.

 Affinity Significantly Improved Wound Closure and Healing Outcomes

Across both baseline wound-duration groups, patients treated with Affinity plus standard of care achieved significantly higher wound closure rates at both Week 12 and Week 16 than those receiving standard care alone (p<0.05). The benefit was observed in ulcers present for more than six months as well as in wounds that had remained unhealed for more than two years, demonstrating efficacy in some of the most challenging venous leg ulcers encountered in clinical practice.

Beyond complete wound closure, the study also reported significant improvements in multiple clinically relevant healing measures. Compared with standard care alone, patients receiving Affinity achieved significantly greater reductions in wound area (>60%), wound depth (>50%), and wound volume (>75%) (p=0.036, p<0.001, and p=0.034, respectively). Additional Cox regression analyses adjusting for baseline wound duration and wound size consistently favored Affinity, demonstrating faster healing across multiple patient subgroups.

Pain Reduction and Favorable Safety Profile

Patients treated with Affinity also experienced significantly greater reductions in ulcer pain by the end of the study compared with those receiving standard care (p=0.0445). Safety outcomes were comparable between treatment groups, with similar overall rates of adverse events. Although eight serious adverse events occurred during the trial, investigators reported that none were related to Affinity treatment, and no new safety concerns were identified.

Findings Expand Clinical Evidence Across Chronic Wound Types

The newly published trial expands the growing body of evidence supporting Affinity across randomized controlled studies and real-world clinical practice. Together with previously reported positive results in diabetic foot ulcers (DFUs), the findings strengthen the evidence supporting Affinity across two of the most prevalent and costly chronic wound types. The results also reinforce the clinical and economic rationale for broader adoption of Affinity in routine wound care.

Company Highlights Clinical Importance of the Findings

Patrick Bilbo, Chief Operating Officer of Organogenesis, said “These clinically meaningful results demonstrate the value of Affinity as a protective barrier in challenging VLUs. Paired with our DFU data, this strengthens the case that Affinity delivers meaningful outcomes for the patients who need it most.”

Study Adds High-Quality Evidence for Challenging Venous Leg Ulcers

Unlike many previous venous leg ulcer studies that enrolled smaller or shorter-duration wounds, this trial specifically evaluated patients with larger, long-standing ulcers that had failed conventional therapy, making the findings particularly relevant to real-world clinical practice. Although the study was not blinded because of the nature of the wound dressing intervention, adjusted statistical analyses were performed to minimize potential bias, and baseline patient and wound characteristics were well balanced between treatment groups. Overall, the publication strengthens the evidence supporting Affinity as an effective treatment option for complex venous leg ulcers and adds high-quality clinical evidence for the use of advanced placental allografts in chronic wound management.

Reference

Hypothermically stored amniotic membrane compared to standard of care for complex venous leg ulcers: a randomised controlled clinical trial

Organogenesis Announces Publication of Peer-Reviewed Clinical Trial Results Demonstrating Clinical Benefit of Affinity™ in the Most Challenging and Complex Venous Leg Ulcers | Organogenesis Holdings Inc.