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Meta-Analysis
. 2020 Jun;17(3):753-764.
doi: 10.1111/iwj.13318. Epub 2020 Mar 2.

Human amniotic membrane allograft, a novel treatment for chronic diabetic foot ulcers: A systematic review and meta-analysis of randomised controlled trials

Ya-Na Su  1 , Ding-Yun Zhao  2 , Yong-Hong Li  1 , Tian-Qi Yu  1 , Huan Sun  3 , Xin-Yu Wu  4 , Xiao-Qin Zhou  5 , Jing Li  1   6
Affiliations
Meta-Analysis

Human amniotic membrane allograft, a novel treatment for chronic diabetic foot ulcers: A systematic review and meta-analysis of randomised controlled trials

Ya-Na Su et al. Int Wound J. 2020 Jun.

Abstract

To evaluate the efficacy and safety of human amniotic membrane (HAM) allograft in treating chronic diabetic foot ulcers (DFUs), a comprehensive search of randomised controlled trials in MEDLINE, EMBASE, PubMed, CENTRAL and Web of Science was conducted to December 7, 2019. Two reviewers independently screened the studies, extracted data, and evaluated the quality of studies. The primary outcome was the proportion of complete healing. The secondary outcomes were mean time to complete healing and adverse events. Statistical analyses were performed using RevMan 5.3. We identified 257 articles, of which 7 articles (465 participants) were included in the meta-analysis. The proportion of complete wound healing in HAM plus standard of care (SOC) group was 3.88 times as high as that in SOC alone (RR: 3.88 [95% CI: 2.34, 6.44]) at 6 weeks, and 2.01 times at 12 weeks (RR: 2.01 [95%CI: 1.45, 2.77]). The intervention group had a significantly shorter time to complete healing (MD: -30.33 days, [95% CI: -37.95, -22.72]). The number needed to treat within 6 weeks was 2.3 ([95% CI: 1.8, 3.1]). No significant difference was shown in adverse events. Results were consistent in a sensitivity analysis. Hence, HAM plus SOC is effective and safe in treating chronic DFUs.

Keywords: diabetic foot ulcer; human amniotic membrane; meta-analysis; systematic review; wound closure.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Figure 1
Figure 1
PRISMA flow diagram of the study selection for the systematic review and meta‐analysis
Figure 2
Figure 2
Risk of bias quality summary
Figure 3
Figure 3
Proportion of complete healing (6 weeks and 12 weeks)
Figure 4
Figure 4
Kaplan‐Meier curves of time to complete healing (HAM + SOC group)
Figure 5
Figure 5
Kaplan‐Meier curves of time to complete healing (SOC group)
Figure 6
Figure 6
Wound‐related infections
Figure 7
Figure 7
Proportion of complete healing (12 weeks) sensitivity analysis. notes: by adding 2 studies that both intervention and control groups were with total contact casts in addition
See this image and copyright information in PMC

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