Background: One million diabetics in the US will develop diabetic foot ulcers (DFUs); 150,000 ulcers will become chronic. 5-24% of these patients will require amputation. Patients who fail standard care and currently available biologic products are left with poor clinical outcomes and increased healthcare costs. In these cases, advanced biologics are recommended.
Methods: We prospectively examined a novel, decellularized, hepatic-derived wound matrix (HD-WM) to treat “hard-to-heal” DFUs in a multi-center study. Fifty-three patients with DFUs between 1 and 12cm2, present for at least 90 days, and following at least 2 applications (2-13, mean 3.2) of other advanced biologics were consented to participate. Fifteen subjects withdrew prematurely (9 Infection, 4 lost to follow-up, 2 withdrew consent). Subjects received standard of care for two weeks, followed by sharp debridement and treatment with the HD-WM. All subjects were off-loaded. Treatment phase lasted 12 weeks or until the wound healed (100% epithelialization, no exudate, and dressing unnecessary). Subjects presented weekly for assessment, dressing change, and HD-WM reapplication as needed (no HD-WM material present in wound and stalled healing). Mean wound area at treatment was 3.6cm2 (± 3.9cm2) and mean ulcer age was 41.1 weeks (12-103 weeks). At treatment, there were no differences in wound age between healed (40.5 weeks) and non-healed (42.2 weeks) subjects and a significant difference in size (2.2cm2 v 5.5cm2 respectively; p=0.008).
Results: Of the 38 subjects completing the study, 22 healed (58.0%) and 16 did not (42%). Mean MIRODERM applications were 2.1 for healed and 4.1 for non-healed. Non-healed wounds were reduced by a mean of 63.7% (7 of 16 reduced by >85%). The mean time to wound closure was 8.1 weeks (2.0-12.0).
Conclusion: We conclude that HD-WM can be successfully used to achieve complete wound healing in these challenging patients who have failed standard treatment and prior treatment with advanced biologic products.