A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers.

"The authors have the following disclosures: Dr CMZ reports no conflicts of interest, although the Professional Education and Research Institute of which he is Medical Director received funding for completion of the study and his role as principal investigator. Dr TES has served as a principal investigator for MiMedx and has received research funds. Dr WWL has provided consultative services to MiMedx. Dr MJC has provided consultative services to MiMedx. All other authors have no potential conflicts to disclose."

"This study was sponsored and funded by MiMedx Group, Inc.. We acknowledge the work of Niki Istwan, RN, an independent consultant, who contributed to the preparation and formatting of the manuscript, and Dr Donald Fetterolf, Stan Harris and Claudine Carnevale from MiMedx® for their assistance with the compilation of study data. The authors have the following disclosures: Dr CMZ reports no conflicts of interest, although the Professional Education and Research Institute of which he is Medical Director received funding for completion of the study and his role as principal investigator. Dr TES has served as a principal investigator for MiMedx and has received research funds. Dr WWL has provided consultative services to MiMedx. Dr MJC has provided consultative services to MiMedx. All other authors have no potential conflicts to disclose."