MARIETTA, Ga., July 30, 2013 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that its study "An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs" has been published in the July 2013 edition of the Journal of Wound Care (Vol. 22, Issue 7, 11 Jul 2013, pp 347 – 351). The electronic publication of the study is available at: http://mimedx.com/images/pdf/JWC__Zelen_Crossover_Study_July_2013.pdf
"This clinical study adds to our series of publications that chronicle the clinical and cost effectiveness of our PURION® processed allografts," said Parker H. "Pete" Petit, Chairman and CEO. "This study is the 'crossover' of the standard of care patients from the randomized controlled trial (RCT) of the diabetic foot ulcer (DFU) patients entitled 'A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers,' which was electronically published recently in the International Wound Journal."
The paper, authored by Dr. Charles Zelen, also was the subject of an award-winning poster presentation at the recent American Podiatry Medical Association (APMA) National Meeting, in which the compelling findings of the "crossover" study were presented.
Patients enrolled in this "crossover" study had been randomized to receive standard care in the DFU clinical trial that compared treatment with EpiFix® to the standard of care. In that RCT, the overall healing rate with application of EpiFix® was shown to be 77% and 92% after 4 and 6 weeks of treatment, respectively, whereas standard care healed 0% and 8% of the wounds, respectively. At completion of the RCT, patients that did not heal with standard care were then offered treatment with EpiFix®. Wounds had been present for an average of over 21 weeks when treatment with EpiFix® was initiated. When reporting outcomes at the predetermined study intervals of 4, 6 and 12 weeks, 55% of the patients achieved complete healing within 4 weeks, 64% within 6 weeks, and 91% within 12 weeks. Although 12 weeks was the predetermined study interval, the 91% complete healing outcome was actually achieved in 9 weeks.