Laurent I, Astère M, Wang KR, Cheng QF, Li QF, et al.
Diabetes therapy : research, treatment and education of diabetes and related disorders. Date of publication 2017 Oct 1;volume 8(5):967-979.
1. Diabetes Ther. 2017 Oct;8(5):967-979. doi: 10.1007/s13300-017-0298-8. Epub 2017
Sep 11.
Efficacy and Time Sensitivity of Amniotic Membrane treatment in Patients with
Diabetic Foot Ulcers: A Systematic Review and Meta-analysis.
Laurent I(1), Astère M(2), Wang KR(1), Cheng QF(3), Li QF(1).
Author information:
(1)Department of Endocrinology, First Affiliated Hospital of Chongqing Medical
University, Chongqing, China.
(2)Department of Oncology, First Affiliated Hospital of Chongqing Medical
University, Chongqing, China.
(3)Department of Endocrinology, First Affiliated Hospital of Chongqing Medical
University, Chongqing, China. cqf19760516@163.com.
INTRODUCTION: Diabetic foot ulcers (DFUs) are complex chronic wounds which have a
major long-term impact on the morbidity, mortality and quality of patients. The
objective of this study was to assess the efficacy and time sensitivity of human
amnion/chorion membrane treatment in patients with chronic DFUs.
METHODS: The Cochrane Library, PubMed, Embase and Web of Science databases were
systematically searched to identify relevant articles up to 10 April 2017. All
randomized controlled trials (RCTs) comparing human amnion/chorion membrane +
standard therapy and standard therapy alone in patients with DFUs were included
in the analysis. Eligible studies were reviewed and data extracted into standard
form. The Cochrane Collaboration's tool for assessing the risk of bias was used.
Review manager version 5.3 software was used for statistical analysis. Data were
analyzed using a random effect model.
RESULTS: Overall, the initial search of the four databases identified 352
published studies; of these, seven RCTS were ultimately included in the
meta-analysis. The overall test effect in the group assessed at 4 weeks was
Z = 4.14 [P < 0.0001; odds ratio (OR) 0.05; 95% confidence interval (CI)
0.01-0.21]. The overall test effect in the group assessed at 6 weeks was Z = 4.28
(P < 0.0001; OR 0.07; 95% CI 0.02-0.23). The overall effect in the group assessed
at 12 weeks was Z = 4.96 (P < 0.00001; OR 0.10; 95% CI 0.04-0.24. The results
showed that patients receiving amniotic membrane + standard therapy had far fewer
incomplete healing wounds than those receiving standard of care alone. Assessment
of the wound healing state at 4 and 6 weeks revealed that the wound healing state
was almost the same, but there was a net difference of wound healing state at
12 weeks.
CONCLUSION: Human amnion/chorion membrane + standard of care treatment heals DFUs
significantly faster than standard of care alone. When using the amnion in
patients with DFUs, the optimal times to assess progress in wound healing should
be 4 and 12 weeks.
DOI: 10.1007/s13300-017-0298-8
PMCID: PMC5630554
PMID: 28895073
