RESEARCH
Early Outcomes from the RENEW Modified Platform Trial of Cellular, Acellular, and Matrix-Like Product Interventions for Diabetic Foot Ulcers
Thomas Serena, MD | Brianna Tramelli, BS | Zwelithini Tunyiswa, BA | Madison Dunn, MS
1 SerenaGroup, Inc., Cambridge, MA | 2 Open Wound Research, Puyallup, WA
Funding: This study was funded by Sequence LifeScience.
INTRODUCTION
The challenge of diabetic foot ulcers
A leading cause of morbidity, cost, and impaired quality of life.
Diabetic foot ulcers (DFUs) represent a major source of morbidity, cost, and impaired quality of life. Standard of care (SOC) for DFUs include sharp debridement, offloading, reducing bacterial load and maintaining moisture balance.
Advanced wound management incorporates cellular, acellular, and matrix-like products (CAMPs) — a broad category of biomaterials, synthetic materials, and biosynthetic matrices that support the repair and/or regeneration of injured tissues through various mechanisms of action.
METHODS
Trial design and enrollment
63 eligible subjects enrolled across 10 U.S. sites.
This RCT (clinicaltrials.gov NCT07086443) was conducted across 10 SerenaGroup, Inc. and affiliated sites in the United States. 63 eligible subjects with nonhealing DFUs were enrolled beginning September 2025 in the amnion, intermediate layer, and chorion (AIC) + SOC arm.
Bayesian statistical analysis was performed to compare wound closure rate of the AIC + SOC arm to a synthetic control (SC) arm derived from a meta-analysis study. Wounds are measured weekly with digital photographic planimetry and physical examination.
INCLUSION & EXCLUSION CRITERIA
Patient eligibility
Inclusion Criteria: At least 18 years of age; diagnosis of type 1 or 2 diabetes mellitus; surface area between 1.0cm² and 15.0cm²; present between 4 and 52 weeks treated with SOC; must be Wagner grade 1 or 2; has adequate perfusion.
Exclusion Criteria: Life expectancy <6 months; ulcer has infection, cellulitis, or osteomyelitis; use of immunosuppressants, cytotoxic chemotherapy, or topical steroids; known allergy/sensitivity to PBS, IPA, processing solutions, reagents, or latex; partial amputation that impedes proper offloading; surface area has reduced in size by >20% in 2 weeks prior to SV or by >25% from SV to TV-1; previously treated with HBOT or CAMP.
ENDPOINTS
Primary and secondary outcomes
Primary Endpoint: The percentage of target ulcers achieving complete wound closure in 12 weeks.
Secondary Endpoint: Percentage wound area reduction from TV-1 to TV-13.
RESULTS
Early interim findings
AIC + SOC treatment showed a 3.4x higher wound closure rate versus standard care alone.
Standardized marginal effects (G-COMP) at week 12 were calculated using the posterior for the primary endpoint. The estimated probability of complete wound closure under SC was 23% (12%–35%), compared with 74% (54%–92%) under the treatment arm. This corresponds to a posterior absolute difference of 50% (27%–71%) and a risk ratio of 3.4 (1.7–5.6) in favor of AIC.
Wound closure probability: 23% under synthetic control vs. 74% under AIC + SOC treatment — a risk ratio of 3.4 in favor of AIC (1.7–5.6, 94% HDI).
CONCLUSIONS
What the data tells us
Early results confirm the trial design is viable and point toward AIC superiority.
For this interim analysis, wounds managed with AIC products trended toward superiority over those managed with SOC. These results confirm that the trial design is viable. Enrollment will continue until the target for statistical power (at α = 0.05) is achieved.
