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Article History

Received: 22 August 2019

Accepted: 30 October 2019

First Online: 15 November 2019

Ethics approval and consent to participate

: This trial has been approved by the South Metropolitan Health Service (SMHS) Health Research Ethics Committee (HREC), approval number RGS000000722.Written informed consent may be obtained at any time prior to randomisation and the commencement of the study.The participants may withdraw consent at any time throughout the course of the study.At any time of the study, the principal investigators will be available to answer questions regarding any aspect of the present study. It will be emphasised and articulated clearly to the participants that they are free to decline to participate and that this will not impact on their current or future treatment in any way. The participants or guardian/nearest relative of a participant may withdraw consent at any time throughout the course of the study. The confidentiality of participant information will be maintained at all times.Informed consent documents and information sheets have been approved for use by the SMHS HREC.

: Not applicable.

: The WA Department of Health is the main funder of this trial, through the 2017 Research Translation Project Grants (Round 11).ReCell® was developed in WA by FW, who is an investigator on the study. To avoid perceived conflict of interest, FW assigned all Intellectual Property for ReCell® to a charitable foundation (Fiona Wood Foundation). All ReCell® kits in WA health are used on a not-for-profit basis. In the case of the present study, the ReCell® kits have been donated by the Fiona Wood Foundation for this study of DFU. The manufacturers (Avita Medical) had no role in the study design.None of the other investigators report a real or perceived conflict of interest for this study.