A Multi‐Centre, Randomised, Controlled Clinical Trial Assessing Cryopreserved Ultra‐Thick Human Amniotic Membrane in the Treatment of Complex Diabetic Foot Ulcers

ABSTRACT TTAX01/Neox 1K are cryopreserved ultra‐thick human amniotic membrane products derived from umbilical cord (cUC) that have been assessed for clinical effectiveness in complex diabetic foot ulcers (DFUs). Herein, a randomised controlled trial was conducted to assess the safety and efficacy of cUC versus standard of care (SOC) for DFUs with exposed bone, tendon, muscle and/or joint capsule and controlled osteomyelitis. A total of 220 eligible patients were enrolled and randomised to receive cUC + SOC ( n = 118) or SOC alone ( n = 102), which included debridement, bone resection, wound dressings, offloading and a 6‐week course of systemic antibiotics. cUC was applied at baseline and reapplied at a minimum of 4‐week intervals if healing was stalled throughout a 16‐week treatment period, for a maximum of four applications. The mean baseline wound area for the cUC and SOC groups was 5.64 ± 5.5 cm 2 and 5.30 ± 4.6 cm 2 , respectively. By 26 weeks, 139 patients achieved complete healing in the intent‐to‐treat population (66.1% cUC group vs. 59.8% SOC group; p = 0.40). An average of 1.67 ± 0.87 applications were required to achieve wound closure in the cUC group. By 50 weeks, 77.1% of patients treated with cUC achieved complete healing compared to 71.6% in the SOC group ( p = 0.29). Adverse event rates, i.e., 89.8% and 87.3%, were comparable between cUC and SOC groups. While there were no significant differences in healing rates or adverse events between the two treatment arms at any time point, this study demonstrates that adjunctive cUC is safe and helps achieve a high healing rate at 50 weeks with less than four applications for complex DFUs that are often excluded in clinical trials.