A Feasibility and Safety Study of a Novel Human Decellularized Dermal Matrix to Accelerate Healing of Neuropathic Diabetic Foot Ulcers in People With Type 1 and Type 2 Diabetes

摘要

Objectives: The purpose of this study was to determine the feasibility and safety of a novel decellularized dermal matrix (DDM) for the treatment of chronic diabetic foot ulcers (DFUs). Methods: An interventional, single-arm, prospective study of DDM for DFU treatment was conducted in 2 Canadian centres from July 1, 2016, to May 30, 2017. Individuals >= 18 years of age with an active DFU of >= 2 weeks and ulcer area >= 1 cm(2) before debridement and who consented to participate were enrolled in this clinical trial. Results: A total of 11 patients were enrolled, with 9 patients (82) having achieved 100 closure between 2 and 8 weeks. The mean and median times to wound closure for these patients were 3.3 and 2.5 weeks, respectively. The mean and median reductions in wound area at 4 weeks post-treatment were 87 and 100, respectively. The proportion of patients having achieved complete healing at 12 weeks was 82. All patients received only 1 DDM application to achieve these results. There were no adverse events related to use of the product. No cases of recurrence during a 1-year follow-up after completion of the study were reported for patients who achieved wound closure. Conclusions: These findings provide evidence that this DDM may be safe and effective for the treatment of chronic, hard-to-heal neuropathic DFUs. Specifically, DDM demonstrated the potential to accelerate healing of DFUs when compared with reported times of 8 to 12 weeks required to achieve closure using the current standard of care. (c) 2022 Canadian Diabetes Association.