Today, the FINAL results of the MIRODERM Hard to Heal Diabetic Foot Ulcer clinical study will be presented at the Society for Advanced Wound Care (SAWC) Spring conference in San Antonio. The final results of 38 patients show that MIRODERM can be considered an appropriate modality to treat difficult-to-heal DFUs.
MIRODERM Biologic Wound Matrix
Hard-to-Heal Diabetic Foot Ulcers
Multi-center, prospective study of patients that previously failed other advanced biologics
Patients were included in the study if they 1) failed at least 2 attempts with an alternative advanced biologic, and 2) had a DFU that had not healed in the previous 3 months.
Primary endpoint: Proportion of healed ulcers at 12 weeks. (Complete wound closure defined as: 100% epithelialization, no exudate and no need for further dressing.)
More than half of these 38 patients (58%) healed within 12 weeks.
An additional 18% closed more than 85% in 12 weeks.
In total, 76% of patients who had previously unhealed wounds were positively impacted!
Prior to being treated with MIRODERM, subjects received a mean of 3.2 other advanced biologic applications. Types of biologics previously used included: EpiFix, REGRANEX, Cytal, Epicord, PriMatrix, Kerecis, Integra, Omnigraft and others.
“The favorable results observed in this challenging patient population are promising with healing rates at or above the rates seen with typical DFUs and other advanced biologics.” – Robert Fridman, DPM, Columbia University Medical Center.