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Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta‐analysis of randomized clinical trials
Author(s) -
Huang Wentao,
Chen Yongsong,
Wang Nasui,
Yin Guoshu,
Wei Chiju,
Xu Wencan
Publication year - 2020
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/wrr.12851
Subject(s) - amnion , medicine , adverse effect , randomized controlled trial , diabetic foot , meta analysis , surgery , adjuvant therapy , cochrane library , clinical trial , diabetic foot ulcer , diabetes mellitus , pregnancy , endocrinology , chemotherapy , fetus , genetics , biology
Abstract Human amnion/chorion membrane therapy has shown advantages in the management of diabetic foot ulcers and its effectiveness has been evaluated in the systematic reviews and meta‐analyses. However, the number of patients included in the previous literatures was small and the safety profile of human amnion/chorion membrane therapy was not concerned. Therefore, we conducted an updated meta‐analysis to better understand the effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers. The PubMed, Embase, Cochrane Library, and ClinicalTrial.gov databases were searched for any randomized clinical trials comparing human amnion/chorion membrane therapy and standard therapy in the treatment of diabetic foot ulcers. Ulcer healing rate was considered as the primary outcome and the secondary outcomes mainly included mean time to ulcer healing and adverse events. Nine RCTs with 541 patients were included. Compared with merely standard therapy, human amnion/chorion membrane therapy plus standard therapy improved the ulcer healing rates at 6 weeks (RR = 3.50, 95% CI: 2.35‐5.21), 12 weeks (RR = 2.09, 95% CI: 1.53‐2.85) and 16 weeks (RR = 1.70, 95% CI: 1.25‐2.30), and also shortened the healing time (MD = −4.58, 95% CI: −5.70 to −3.46). Meanwhile, no significant difference was observed in the number of patients with adverse events (RR = 0.56, 95% CI: 0.31‐1.03) between two groups. This meta‐analysis suggests that human amnion/chorion membrane therapy as an adjuvant treatment could promote the healing of diabetic foot ulcers and has a safety profile. More evidence from large high‐quality randomized clinical trials with long follow‐up duration are in urgent need to further confirm our findings.