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Healing hard-to-heal diabetic foot ulcers: the role of dehydrated amniotic allograft with cross-linked bovine-tendon collagen and glycosaminoglycan matrix

02 July 2021
Volume 5 · Issue 3

Abstract

The treatment of diabetic foot ulcers is complex and costly with an increased risk for infection, which may even lead to amputation. This prospective case series aims to assess the effectiveness of a dehydrated amniotic membrane allograft combined with a bilayer dermal matrix for healing complicated foot ulcers in patients with comorbidities. A total of six patients with complicated full-thickness ulcers and comorbidities, such as diabetes and peripheral vascular disease were treated with this technique. Each wound was measured intraoperatively just before graft application, at 14 days after application, and then at weeks 4, 8, and 12. Changes in wound volume and area were compared over time. One patient had complete wound closure by week eight, a second patient by week 12. The other four patients had wounds that decreased in size during the course of 12 weeks. The mean decrease in wound volume was 73.5% post-removal of the bilayer dermal matrix after two weeks of application. At week 12, the mean decrease in wound area and volume were 93.2% and 97.1%, respectively. This case series provides initial evidence that the combination of dehydrated amniotic membrane allograft with bilayer dermal matrix promotes complete wound closure in patients with comorbidities that may impede wound healing. Further clinical trials are needed to confirm these results.

The lifetime risk of an individual with diabetes developing a foot ulcer is estimated to be between 15–25%.1,2 The treatment of diabetic foot ulcers (DFU) is complex and costly, with a large percentage at risk of becoming infected, and 20–25% of these may result in amputation, with an estimated annual global cost of $9–13 billion.3,4,5

The standard of care (SOC) for DFUs includes sharp debridement, wound care dressings, maintaining a moist wound environment, offloading, infection control, and revascularisation procedures.6,7 DFUs are often slow to close, may not heal completely, or may require surgical techniques to enhance closure.8,9 A meta-analysis revealed that patients with DFUs treated with SOC had only a 24% healing rate after 12 weeks.10

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