Use of hypothermically stored amniotic membrane on diabetic foot ulcers: a multicentre retrospective case series

Abstract

Objective: The aim of this retrospective case series was to report on the outcomes of diabetic foot ulcers (DFUs) managed with hypothermically stored amniotic membrane (HSAM). Method: Deidentified case data of patients who received HSAM were obtained from wound care sites across the US. Data were collected, beginning at the first patient visit to the wound care site (first presentation), at the visit in which the first HSAM application occurred (baseline), and at each subsequent visit over 12 weeks of treatment (follow-up). All patients received standard of care (SoC) between first presentation and baseline. Results: Of the 50 patients in the study, 68% were male. Mean age of the entire cohort was 66.7 years. Of the DFUs, 88% were present for <6 months at first presentation. Mean wound area was 3.5cm2, and mean percentage area reduction was –68.3% from first presentation to baseline. The mean number of HSAM applications was 5.5, and mean number of days between applications was 7.5. A >60% area reduction was attained in 96.0% of DFUs, and 78% attained complete wound closure (CWC) by week 12. The median time to CWC was 55 days. Conclusion: The results of this retrospective case series suggest positive outcomes for DFUs managed with HSAM. A reduction in time to CWC may lead to lesser financial burden and improved quality of life for DFU patients. Declaration of interest: The authors have no conflicts of interest.