A systematic review on clinical outcomes of human amniotic membrane preparations in the management of venous leg ulcers

Abstract

Introduction: Venous leg ulcers are the commonest type of chronic lower leg ulcers worldwide. It impacts the patient’s quality of life significantly. Our objective was to assess current evidence onusing human amniotic membranes (HAM) in venous leg ulcer management. Methods: Google Scholar, PubMed, and the Cochrane library were utilized to search the following search terms (MeSH terms in PubMed) in the abstract field or in the title, “Amnion” OR “Placenta” AND “Varicose ulcer “OR “Stasis ulcer” OR “Chronic venous ulceration” in studies published until the 1st of March 2022. We used standard methods to assess the quality of the published articles. The articles thus included were cohort studies (both retrospective and prospective) and randomized control trials. Results: When the above criteria were used in the search, 12, 8, 15,6, and 4 citations were found in MEDLINE, Cochrane Library, Google Scholar, Embase, and Web of Science respectively. The 15 nonduplicate studies were screened with the inclusion and exclusion criteria, we selected 7 studies for this review. However, the amniotic membrane preparations used in these studies were not uniform. All randomized controlled trials (n=3) have concluded that there is an improvement in healed ulcer percentage at the end of the study in the interventional group when compared to the control group, which was statistically significant (p<0.05%). The percentage of ulcers that had healed at the end study was 60% in interventional groups of the above trials. One prospective study showed that the recurrence rate was less than 30% at a 3-year follow-up examination. We couldn't perform a meta-analysis due to study heterogeneity. Conclusion: Current scientific evidence indicates that amniotic membrane preparations can be utilized in promoting chronic forms of venous leg ulcers adjunctive to traditional treatment or as second-line therapy.