A Multi-Centre, Randomised, Controlled Clinical Trial Assessing Cryopreserved Ultra-Thick Human Amniotic Membrane in the Treatment of Complex Diabetic Foot Ulcers
Summary: Multicenter RCT (n=220 Wagner 3/4 DFUs with exposed bone/tendon/muscle/joint and controlled osteomyelitis) compared cryopreserved ultra-thick human amniotic membrane (cUC, TTAX01/Neox 1K) + SOC vs SOC alone. At 26 weeks, 66.1% cUC + SOC healed vs 59.8% SOC (p=0.40); median time 106 vs 104 days (p=0.99). At 50 weeks, 77.1% vs 71.6% (p=0.29). Average 1.67 cUC applications; comparable AEs (90% both). Demonstrates cUC safety/efficacy as adjunct for severe DFUs often excluded from trials, with potential cost savings via fewer applications.
Key Highlights:
- Population: 220 patients; mean area 5.5 cm²; 6-week antibiotics.
- Healing: 66.1% at 26 weeks (cUC) vs 59.8% SOC; 77.1% at 50 weeks.
- Applications: Mean 1.67; max 4 over 16 weeks.
- Safety: AEs 89.8% vs 87.3%; amputations 11.9% vs 18.6% (NS).
- Authors: Joseph Caporusso, Travis Motley, John C Lantis II et al.
Keywords: cUC amniotic, complex DFUs, RCT, healing rates, exposed bone, Joseph Caporusso, Travis Motley, John C Lantis