Zelen CM, Gould L, Serena TE, Carter MJ, Keller J, Li WW, et al.
International wound journal. Date of publication 2015 Dec 1;volume 12(6):724-32.
1. Int Wound J. 2015 Dec;12(6):724-32. doi: 10.1111/iwj.12395. Epub 2014 Nov 26.
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.
Zelen CM(1), Gould L(2), Serena TE(3), Carter MJ(4), Keller J(5), Li WW(6).
Author information:
(1)Professional Education and Research Institute, Roanoke, VA, USA.
(2)Wound Recovery Center, Kent Hospital, Warwick, RI, USA.
(3)Serena Group, Cambridge, MA, USA.
(4)Strategic Solutions, Inc., Cody, WY, USA.
(5)Shenandoah Lower Extremity Research, Daleville, VA, USA.
(6)The Angiogenesis Foundation, Boston, MA, USA.
A prospective, randomised, controlled, parallel group, multi-centre clinical
trial was conducted at three sites to compare the healing effectiveness of
treatment of chronic lower extremity diabetic ulcers with either weekly
applications of Apligraf(®) (Organogenesis, Inc., Canton, MA), EpiFix(®) (MiMedx
Group, Inc., Marietta, GA), or standard wound care with collagen-alginate
dressing. The primary study outcome was the percent change in complete wound
healing after 4 and 6 weeks of treatment. Secondary outcomes included percent
change in wound area per week, velocity of wound closure and a calculation of the
amount and cost of Apligraf or EpiFix used. A total of 65 subjects entered the
2-week run-in period and 60 were randomised (20 per group). The proportion of
patients in the EpiFix group achieving complete wound closure within 4 and 6
weeks was 85% and 95%, significantly higher (all adjusted P-values ≤ 0·003) than
for patients receiving Apligraf (35% and 45%), or standard care (30% and 35%).
After 1 week, wounds treated with EpiFix had reduced in area by 83·5% compared
with 53·1% for wounds treated with Apligraf. Median time to healing was
significantly faster (all adjusted P-values ≤0·001) with EpiFix (13 days)
compared to Apligraf (49 days) or standard care (49 days). The mean number of
grafts used and the graft cost per patient were lower in the EpiFix group
campared to the Apligraf group, at 2·15 grafts at a cost of $1669 versus 6·2
grafts at a cost of $9216, respectively. The results of this study demonstrate
the clinical and resource utilisation superiority of EpiFix compared to Apligraf
or standard of care, for the treatment of diabetic ulcers of the lower
extremities.
© 2014 The Authors. International Wound Journal published by Medicalhelplines.com
Inc and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.12395
PMID: 25424146 [Indexed for MEDLINE]
