Treatment of diabetic foot ulcers with dehydrated amniotic membrane allograft: a prospective case series

Objective: A diabetic foot ulcer (DFU) is one of the many potential complications associated with diabetes. If not effectively and rapidly treated, DFUs can result in lower extremity amputations. This prospective case series aimed to assess the effectiveness of a dehydrated amniotic-derived tissue allograft (DAMA), with regards to time to wound closure and total number of applications. Method: Patients were recruited with a neuropathic non-healing DFU(s) despite standard care for at least 4 weeks before the study. The number of DAMA applications and time between applications was based on the physician's judgment. For the majority of patients (n=13/14), offloading, usually total contact casting (TCC), was used in conjunction with DAMA. Wounds were assessed, measured, and photographed every 1-2 weeks. Results: Cases included 14 patients (11 men, 3 women; mean age 56.7 +/- 9.1 years) with 15 non-healing neuropathic DFUs with a mean baseline wound area of 6.5 +/- 11.6cm(2) (median: 2.2cm(2); range: 0.1-44.2cm(2)) and mean volume of 4.3 +/- 10.9cm(3) (median: 0.3cm(3); range: 0-39.8cm(3)). All patients in this series achieved complete wound closure within a median time of 5 weeks (range: 1-14 weeks). Wound area was reduced by a median of 58.3% at week 1 and 74.1% at week 3, and volume by a median of 62.8% at week 1, 97.4% at week 3 and by a median of 100% at week 5 and all time points thereafter. Patients received a median of 2 DAMA applications (range: 1-11). In those that required more than 1 application (n=12), DAMA was applied at intervals of 1 week (n=3) or >= 2 weeks (n=9). Smaller wounds (areas <2.2cm(2)) closed rapidly (<1 month, 1-2 applications), whereas larger wounds (>2.2cm(2)) required >2 weekly/biweekly applications. Conclusion: The use of DAMA, particularly when coupled with TCC, led to wound closure of DFUs in all patients in this case series, including complex patients with DFUs of >= 1 year in duration, lack of prior response to conservative treatment measures, area >10cm(2) and/or multiple comorbidities. Prospective randomised trials would help to elucidate the precise role of DAMA in these encouraging results.