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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

Published:April 06, 2022DOI:https://doi.org/10.1016/j.jcjd.2022.03.010
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      ABSTRACT

      OBJECTIVES

      The purpose of this study was to investigate 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 two Canadian from July 1st, 2016 to May 30th, 2017. Individuals 18 or older, with an active DFU for at least 2 weeks, ulcer area of ≥1 cm2 prior to debridement 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 2-8 weeks. The mean and median times to wound closure for these patients was 3.3 and 2.5 weeks, respectively. The mean and median reduction in wound area at 4 weeks post-treatment was 87 and 100 %, respectively. The proportion of patients having achieved complete healing at 12 weeks was 82%. All patients received only 1 application of the DDM to achieve these results. There were no adverse events related to the product. No cases of recurrence during a one-year follow-up after completion of the study have been reported for patients who achieved wound closure in the study.

      Conclusions

      These findings provide evidence that this DDM may be safe and effective for the treatment of chronic, hard to heal neuropathic DFUs. Specifically, it demonstrated the potential to accelerate the healing rate of DFUs when compared with reported times of 8-12 weeks required to achieve closure using standard of care.

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