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Meta-Analysis
. 2022 Sep 14;15(1):71.
doi: 10.1186/s13047-022-00575-y.

Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis

Yasmine Adel Mohammed  1   2 , Hossam Khaled Farouk  3   4 , Mohamed Ibrahim Gbreel  3   5 , Abdelrahman Mahmoud Ali  3   6 , Ali Ashraf Salah  3   6 , Anas Zakarya Nourelden  3   7 , Mohamed Mahmoud Abd-El Gawad  3   4
Affiliations
Meta-Analysis

Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis

Yasmine Adel Mohammed et al. J Foot Ankle Res. .

Abstract

Background: Diabetic foot ulcer (DFU) is one of the most serious diabetic complications. DFU is an open wound that usually occurs in the foot sole due to poor blood glucose control, peripheral neuropathy, and poor circulation. The human amniotic allograft membrane is a biological wound dressing derived from the amniotic membrane. It contains amino acids, nutrients, cytokines, and growth factors that make the growth process easier.

Objective: To compare dehydrated human amnion and chorion allograft (DHACA) plus the standard of wound care (SOC) with the SOC alone.

Methods: We searched for randomized clinical trials (RCTs) on PubMed, Scopus, Cochrane, and Web of Science till April 2021 using relevant keywords. All search results were screened for eligibility. We extracted the data from the included trials and pooled them as mean difference (MD) or risk ratio (RR) with the 95% confidence interval (CI) using Review Manager software (ver. 5.4).

Results: The pooled effect estimate from 11 RCTs showed that DHACA was superior to SOC regarding the complete wound healing in both 6th and 12th week (RR = 3.78; 95% CI: [2.51, 5.70]; P < 0.00001) and (RR = 2.00; 95% CI: [1.67, 2.39], P < 0.00001 respectively). Also, the analysis favored the DHACA regarding the mean time to heal in the 12th-week (MD = -12.07, 95%CI: [-19.23, -4.91], P = 0.001). The wound size reduction was better with DHACA (MD = 1.18, 95%CI: [-0,10, 2.26], P = 0.03).

Conclusion: Using DHACA with SOC is safer and more effective than using SOC alone for DFU patients.

Keywords: AmnioBand; Amniotic allograft; Diabetic foot ulcer; EpiFix; Grafix; Human amnion membrane.

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Conflict of interest statement

None to declare.

Figures

Fig. 1
Fig. 1
PRISMA flow chart of the literature search
Fig. 2
Fig. 2
Cochrane risk of bias summary of the included studies
Fig. 3
Fig. 3
Funnel plot for publications bias assessment of the included studies in the outcome of the complete wound healing
Fig. 4
Fig. 4
A comparison between (DHACA) + (SOC) group and the (SOC) alone group in terms of (A) complete wound healing. (B) risk of adverse events. (C) Mean difference Wound size reduction
See this image and copyright information in PMC

References

    1. Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019;157:107843. - PubMed
    1. Woods TJ, Tesfay F, Speck P, Kaambwa B. Economic evaluations considering costs and outcomes of diabetic foot ulcer infections: A systematic review. PLoS ONE. 2020;15(4):e0232395. doi: 10.1371/journal.pone.0232395. - DOI - PMC - PubMed
    1. Zhang P, Lu J, Jing Y, Tang S, Zhu D, Bi Y. Global epidemiology of diabetic foot ulceration: a systematic review and meta-analysis†. Ann Med. 2017;49(2):106–116. doi: 10.1080/07853890.2016.1231932. - DOI - PubMed
    1. Noor S, Zubair M, Ahmad J. Diabetic foot ulcer - A review on pathophysiology, classification and microbial etiology. Diabetes Metab Syndr Clin Res Rev. 2015;9(3):192–199. doi: 10.1016/j.dsx.2015.04.007. - DOI - PubMed
    1. Kolluru GK, Bir SC, Kevil CG. Endothelial dysfunction and diabetes: Effects on angiogenesis, vascular remodeling, and wound healing. Int J Vasc Med. 2012;2012:918267. - PMC - PubMed