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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
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
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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.

      Key words

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      Article Info

      Publication History

      Accepted: March 29, 2022
      Received in revised form: February 9, 2022
      Received: July 15, 2021

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Key Messages:

      – Despite several advances in wound treatments, wounds hard-to-heal wound such as DFU still requires between 12 to 16 weeks to achieve complete closure.

      – The mean and median times to closure for these patients was 3.3 and 2.5 weeks, respectively and time to 50% closure for the entire 11 patients treated was less than 1 week.

      – This DDM has demonstrated a great potential to achieve wound closure for people with DFUs within less than 4 weeks period.

      Conflicts of Interests

      This study was funded through a research grant from the Canadian Institute of Health Research (CIHR), provided to Dr. Gratzer to develop this clinical study to pilot test his novel human DMM developed during his role as an Associate Professor in the School of Biomedical Engineering, Dept. of Surgery, Dalhousie University, Halifax. Dr Gratzer is also the Co-Founder and Chief Scientific Officer for DeCell Technologies Inc and declare that his company has not received or provided any funding to develop this study. Dr. Costa is a wound care consultant at Advanced Wound Care Consultancy and Education Inc. and also declared that her company did not receive or provided any funding to develop this study. All authors declare no conflict of interest related to this research. The content of this article was expressly written by the authors listed and everyone contributed and agreed with the final draft of this manuscript.

      Author contributions

      IGC contributed to the conceptualization, design of methodology, analysis and interpretation of data; drafted the first and final versions of this manuscript. MG, SL and AM provided great contribution to data collection and analysis and revised the manuscript critically. PFG acquired the funding, supervised data collection and contributed to the design of the methodology, and revised the manuscript critically for important intellectual content. All authors reviewed and approved the final version to be published.

      Identification

      DOI: https://doi.org/10.1016/j.jcjd.2022.03.010

      Copyright

      © 2022 Canadian Diabetes Association.

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