Treatment of Hard-to-heal Diabetic Foot Ulcers With a Hepatic-derived Wound Matrix (HD-WM)

Over 30 million people in the U.S. suffer from diabetes. Diabetics have a 25% lifetime incidence of developing a diabetic foot ulcer (DFU), and 4% -10% will have a DFU at any given time. Standard of care treatment may only heal up to 24% of these ulcers after 12 weeks, suggesting standard treatment is generally insufficient.

We prospectively evaluated a novel, hepatic-derived wound matrix* (HD-WM) to treat hard-to-heal DFUs in a multicenter study. Nine centers enrolled 53 diabetic patients with DFUs having a median area at treatment of 3.5 cm2 (range 1- 16cm2), present for at least 90 days, and non-responsive to a median of 3 applications (range 2-16) of one or more advanced wound care product.  Fifteen subjects withdrew prematurely (9 infection, 4 lost to follow-up, 2 withdrew consent). Patients were treated with standard of care and offloading for two weeks, followed by sharp debridement and treatment with the HD-WM.  Patients continued weekly visits for assessment, dressing change, and reapplication of the HD-WM as needed until the wound healed (100% epithelization, no exudate, dressing not required) or went 12-weeks posttreatment without healing.

Complete wound closure occurred in 22 of the 38 patients (57.9%) within the 12-week study period.  In contrast, 16 of the 38 (42.1%) wounds failed to completely heal; however, of those 16 wounds, 7 (58.3%) had closed 85% or greater by week 12. Mean time to wound closure was 8.1 weeks with a median 1 application of the HD-WM. Closure of the wound by 50% or greater at week 4 was highly predictive of complete wound closure by 12 weeks. A Kaplan Meier analysis of the data suggests a 71.4% healed rate at 13 weeks post-treatment.

The HD-WM under evaluation did well at closing difficult-to-heal wounds with minimal applications. These wounds had been open for a mean of 41.1 weeks and had previously failed at least 2 applications of 1 or more advanced treatment modalities. Results are consistent with a previous study and indicate that this HD-WM shows a robust potential to manage wounds and is an appropriate technology to treat difficult-to-heal DFUs.

Trademarked Items (if applicable): *MIRODERM®, (Reprise Biomedical)

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