Treatment of Failed Diabetic Foot Ulcers With a Novel Decellularized Porcine-liver Wound Matrix: Preliminary Outcomes From a Subset of Centers in a Prospective Multicenter Trial

INTRODUCTION: A majority of diabetic foot ulcers (DFUs) are refractory to standard of care. Many require treatment with advanced biologic products in an attempt to heal ulcers prior to developing worse complications. Patients who fail to respond to current standard of care advanced biologic products are left with poor clinical outcomes and increased health care spending. 

OBJECTIVE: The ability of a novel, decellularized, porcine-liver extracellular matrix (ECM) to treat failed or “hard-to-heal” DFUs is being prospectively assessed in a multicenter study. 

MATERIALS AND METHODS: Patients with a DFU between 1 cm² and 12 cm², present for at least 90 days, and following a minimum of 2 treatment attempts with advanced biologics were consented to participate following a 4-week washout period. Following consent, patients received standard of care for 2 weeks followed by sharp debridement and treatment with the novel, decellularized, porcine-liver ECM. All patients received either a controlled ankle motion walker or offloading shoe with customizable peg insert. The treatment phase lasted 12 weeks or until the wound healed as defined by 100% epithelialization, no exudate, and no need for dressing. Patients presented weekly for assessment, dressing change, and ECM reapplication as needed (no ECM material present in wound and stalled wound healing).

RESULTS: Majority of the 24 patients were male (66.7%) with a mean age of 62 years and a mean body mass index of 30.9. Four patients withdrew prematurely. The mean wound area was 3.4 cm² (range, 1.0 cm²–10 cm²) and mean ulcer age at treatment was 210 days (range, 91–1071 days). Patients had a median of 2 previous treatment attempts (2–13) with advanced biologics. Of the 24 patients enrolled, 11 healed within 12 weeks (55.0%) while 9 failed to achieve closure (45%). For patients whose wound healed, the mean time to closure was 7.2 weeks. 

CONCLUSIONS: These favorable results are promising with healing rates at or above those seen with typical DFUs and other advanced biologics in this challenging patient population.

CITATION
Fridman R, Rafat P, Horn DB, Van Gils C. Treatment of failed diabetic foot ulcers with a novel decellularized porcine-liver wound matrix: preliminary outcomes from a subset of centers in a prospective multicenter trial. Poster presented at: Symposium on Advanced Wound Care Fall; November 2-4, 2018; Las Vegas, NV.

Product: Miroderm (Miromatrix Medical Inc, Eden Prairie, MN)

This abstract was not subject to the WOUNDS peer-review process.