Cryopreserved amniotic membrane in the treatment of diabetic foot ulcers: a case series

Abstract

Objective: The amniotic membrane (AM) is a tissue with low immunogenity and high therapeutic potential due to its anti-inflammatory, anti-fibrotic and antimicrobial effects. This paper describes the use of cryopreserved amniotic membrane allografts to treat diabetic foot ulcers (DFUs) in patients with diabetes. Method: In this case series, AM was processed to obtain a final medicinal product: cryopreserved amniotic membrane. cryopreserved AM was applied every 7–10 days until total epithelialisation of the DFUs. Results: A total of 14 patients with DFUs (median size: 12.30cm, (range: 0.52–42.5cm2) were treated and followed up until complete closure (median time: 20 weeks, range: 7–56 weeks). Patients received 4–40 AM applications. All patients in this study achieved complete epithelialisation of the wound. No adverse events were observed. Conclusion: AM is a feasible and safe treatment in complex DFUs. Furthermore, the treatment is successful in achieving epithelialisation of long-evolution, unhealed wounds resistant to conventional therapies.

Systematic review on the rational use of amniotic membrane allografts in diabetic foot ulcer treatment

“…In one prospective study [14], the mean duration of ulcer was more than 56 days and the mean ulcer size was 12.30 cm 2 in comparison the other prospective study [15] these two parameters were more than 28 days and 6.5 cm 2 . Median ulcer closure times were 20 weeks and 5 weeks, respectively.…”

“…We found 8 randomized control trials [1,2,5,[9][10][11][12][13] and all were performed in the United States and five of those were multicenter trials. Out of the 2 prospective studies one was done in Spain [14] and the other in the United States [15]. Both retrospective studies [16,17] were also performed in the United States.…”

“…The main limitations of these studies were the heterogeneity study methods and outcomes, limited number of RCTs and small number of the of study participants. Except one study [14] other studies were conducted in the USA limiting the generalization of the results to the global population. A meta-analysis could not be performed due to study heterogeneity, and publication bias was not assessed due to the small number of available studies for each comparison.…”

Use of cryopreserved human amniotic membrane in the treatment of skin ulcers secondary to calciphylaxis

“…AM has been successfully used as a biological dressing for treating many types of wounds. 9,14 Some studies report the analgesic effect of the membrane when applied to wounds. 11 These findings are consistent with the observations of this report, where following treatment with AM, the patient experienced a reduction in pain using VAS scale.…”

“…The structure of the AM is able to provide a matrix that promotes cell migration and proliferation while AM epithelial cells synthesize and release biologically active factors. This tissue also has anti‐inflammatory, anti‐fibrotic, antibacterial, and analgesic properties 8‐14 …”