Findings from a multicenter study comparing AMNIOEXCEL® Amniotic Allograft Membrane against standard-of-care for treating diabetic foot ulcers has been published in the WOUNDS Journal. Data from this new study shows 46% (‡ Per Protocol population) of subjects treated with AMNIOEXCEL® plus standard-of-care achieved complete wound closure by six weeks, while 0% of subjects treated with standard-of-care alone achieved complete wound closure.
A Prospective, Randomized, Multicenter and Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft (DAMA - AMNIOEXCEL®) compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcers.
Robert J. Snyder, DPM, MSc; Kenneth Shimozaki, DPM; Arthur Tallis, DPM; Michael Kerzner, DPM;
Alexander Reyzelman, DPM; Dimitrios Lintzeris, DO; Desmond Bell,DPM; Randi L. Rutan; and Barry Rosenblum, DPM
This prospective, multicenter, randomized, controlled clinical trial (RCT) with standardized ulcer care and off-loading incorporated a 2-week run-in period. Despite a short 6-week study period, ANIOEXCEL® + SOC achieved significantly greater (p=0.008) ulcer closure rates over SOC alone.
WOUNDS, March 2016
In this trial:
- Stratified randomization yielded a statistically balanced demographic and wound characteristic distribution between groups
- Endpoint of complete ulcer closure objectively adjudicated with photographs and ulcer tracings
- Comparable adverse event profile between groups
- Both the Intent To Treat (all randomized subjects) and the Per Protocol (all completing the study) populations demonstrated statistically significantly greater ulcer closure rates with the addition of AMNIOEXCEL® to the standard of care regimen.
AMNIOEXCEL® Amniotic Allograft Membrane is a novel human placental-based tissue product. The membrane forms a protective covering over the wound while providing the key components found in human amnion including an intact ECM (extracellular matrix), cytokines and other growth factors. The dehydrated membrane is easy to store and use and helps provide the optimal environment to repair, reconstruct and replace wound tissue.
views for evidence
1. Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, et al. Comprehensive foot examination and risk assessment: A report of the task force of the foot care interest group of the ADA, with endorsement by the AACE. Diabetes Care 2008; 8: 1679-1685. 2. Holzer SE, Camerota A, Marens L, et al. Costs and duration of care for lower extremity ulcers in patients with diabetes. Clin Ther 1998; 20:169-181. 3. Davis JW. Skin transplantation with a review of 550 cases at the Johns Hopkins Hospital. Johns Hopkins Med J. 1910; 15: 307-396. 4. Zelen CM, Serena TE et al. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J ISSN 1742-4801. 2013; June: 1-6. 5. Ueta M, Kweon M-N, Sano Y, Sotozono C, et al. Immunosuppressive properties of human amniotic membrane for mixed lymphocyte reaction. Clin Exp Immun 2002; 129:464-470. 6. Hao Y, Ma DH, Hwang DG, Kim WS, Zhang F. Identification of antiangiogenic and anti-inflammatory proteins in human amniotic membrane. Cornea 2000; 19: 348-352. 7. Kjaergaard N, Hein M, Hyttel L, Helmig RB, Schonheyder HC, Uldbjerg N, Madsen H. Antibacterial properties of human amnion and chorion in vitro. Eur J Obst Gyn & Reprod Bio 2001; 94: 224-229. 8. Parolini O, et al. Human term placenta as a therapeutic agent: from the first clinical applications to future perspectives. In: Berven E, editor. Human placenta: structure and development. Hauppauge, New York: Nova Science Publishers, 2012: 1-48.