Biomaterials company MiMedx Group, Inc. developer, manufacturer and marketer of products processed from human amniotic membrane, has announced that a new comparative study into the use of its allograft tissue in diabetic foot ulcers, has been published in the International Wound Journal. Study results show that the biomaterial clearly works and furthermore that by applying it weekly rather than biweekly, healing is accelerated.
MiMedx® develops, manufactures and markets its patent protected regenerative biomaterial products and bioimplants, processed from human amniotic membrane. The company’s biomaterial platform technologies include AmnioFix® and EpiFix®, tissue technologies processed from human amniotic membrane that is derived from donated placentas.
The new prospective, randomised, comparative study is entitled; “A prospective, randomized comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers”.
Authored by Charles M. Zelen, DPM, FACFAS; Thomas E. Serena MD, FACS; and Robert J. Snyder, DPM, MSc. it has been published electronically in the International Wound Journal.
The study singled out patients with non-infected ulcers of greater than 4 weeks duration, including only 40 patients whose wounds had not exhibited rapid closure under conservative care. This group was randomised to receive either weekly or biweekly application of EpiFix®. All study subjects received a non-adherent, moist dressing with compressive wrapping, and all wounds were off loaded. The primary study outcome was mean time to healing.
Overall, in the 12 week study period, 37 out of 40 patients, or 92.5%, of the DFUs healed completely. Of these 37 patients, the mean time to complete healing was 2.4 weeks for those patients receiving weekly applications and 4.1 weeks for those receiving biweekly applications. These findings show that wounds treated with weekly applications heal more rapidly, and that even the wounds treated with biweekly applications had rapid healing rates.
Parker H. “Pete” Petit, Chairman and CEO said, “We are proud to present yet another clinical trial that shows superior healing rates of over 92% with our EpiFix® allograft. This study clearly reiterates the results of other clinical studies that our EpiFix® allograft is a clinically and cost effective therapy. The additional significance of this clinical trial is that it confirms that patients receiving weekly applications of EpiFix® achieved complete healing in nearly half the time as those receiving biweekly applications. This study provides physicians with the clinical evidence that applying EpiFix® at more frequent intervals will accelerate complete healing.”
Bill Taylor, President and COO, stated, “While the overall healing rates at the end of the 12 week study period were equally as impressive with greater than 92% complete healing, the weekly group healed 41.5% faster than those in the biweekly group. More rapid healing is essential in improving the patient’s return to normal function and mobility, as well as, decreasing clinical costs and preventing the complications inherent in long-term medical treatments.”
Source: MiMedx, Inc., PR Newswire