Serena TE, Yaakov R, Moore S, Cole W, Coe S, Snyder R, Patel K, Doner B, Kasper MA, Hamil R, Wendling S, Sabolinski ML, et al.
Journal of comparative effectiveness research. Date of publication 2020 Jan 1;volume 9(1):23-34.
1. J Comp Eff Res. 2020 Jan;9(1):23-34. doi: 10.2217/cer-2019-0142. Epub 2019 Nov
6.
A randomized controlled clinical trial of a hypothermically stored amniotic
membrane for use in diabetic foot ulcers.
Serena TE(1), Yaakov R(2), Moore S(2), Cole W(3), Coe S(3), Snyder R(4), Patel
K(5), Doner B(5), Kasper MA(6), Hamil R(2), Wendling S(7), Sabolinski ML(8).
Author information:
(1)SerenaGroup® Research Foundation, Cambridge, MA 02140, USA.
(2)SerenaGroup Research Foundation, Cambridge, MA 02140, USA.
(3)Kent State University College of Podiatric Medicine, Independence, OH 44131,
USA.
(4)Barry University School of Podiatry Medicine, North Miami Beach, FL 33168,
USA.
(5)D & P Medical Group, Pittsburgh, PA 15237, USA.
(6)Martin Foot & Ankle, York, PA 17402, USA.
(7)Organogenenis, Inc, Canton, MA 02021, USA.
(8)Sabolinski LLC, Franklin, MA 02038, USA.
Aim: Determine the effectiveness of hypothermically stored amniotic membrane
(HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods: A
randomized controlled trial was conducted on 76 DFUs analyzed digitally.
Results: Cox wound closure for HSAM (38 wounds) was significantly greater (p =
0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound
closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16-2.70). HSAM showed
>60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04)
versus SOC. Conclusion: HSAM increased frequency and probability of wound
closure in DFUs versus SOC.
DOI: 10.2217/cer-2019-0142
PMID: 31691579 [Indexed for MEDLINE]
