Zelen CM, Serena TE, Snyder RJ, et al.
International wound journal. Date of publication 2014 Apr 1;volume 11(2):122-8.
1. Int Wound J. 2014 Apr;11(2):122-8. doi: 10.1111/iwj.12242. Epub 2014 Feb 21.
A prospective, randomised comparative study of weekly versus biweekly application
of dehydrated human amnion/chorion membrane allograft in the management of
diabetic foot ulcers.
Zelen CM(1), Serena TE, Snyder RJ.
Author information:
(1)Department of Clinical Research, Professional Education and Research
Institute, Inc., Roanoke, VA, USA.
The aim of this study is to determine if weekly application of dehydrated human
amnion/chorion membrane allograft reduce time to heal more effectively than
biweekly application for treatment of diabetic foot ulcers. This was an
institutional review board-approved, registered, prospective, randomised,
comparative, non-blinded, single-centre clinical trial. Patients with
non-infected ulcers of ≥ 4 weeks duration were included for the study. They were
randomised to receive weekly or biweekly application of allograft in addition to
a non-adherent, moist dressing with compressive wrapping. All wounds were
offloaded. The primary study outcome was mean time to healing. Overall, during
the 12-week study period, 92·5% (37/40) ulcers completely healed. Mean time to
complete healing was 4·1 ± 2·9 versus 2·4 ± 1·8 weeks (P = 0·039) in the biweekly
versus weekly groups, respectively. Complete healing occurred in 50% versus 90%
by 4 weeks in the biweekly and weekly groups, respectively (P = 0·014). Number of
grafts applied to healed wounds was similar at 2·4 ± 1·5 and 2·3 ± 1·8 for
biweekly versus weekly groups, respectively (P = 0·841). These results validate
previous studies showing that the allograft is an effective treatment for
diabetic ulcers and show that wounds treated with weekly application heal more
rapidly than with biweekly application. More rapid healing may decrease clinical
operational costs and prevent long-term medical complications.
© 2014 The Authors. International Wound Journal © published by
Medicalhelplines.com Inc and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.12242
PMCID: PMC4235421
PMID: 24618401 [Indexed for MEDLINE]
