November 10, 2020
HIFLO Trial Evaluates MicroVascular Tissues mVasc Wound Healing Device
November 10, 2020—MicroVascular Tissues, Inc., a regenerative medicine company, announced positive results of its HIFLO trial assessing patient outcomes after treatment with the company’s mVasc microvascular tissue graft product compared to standard of care (SOC) alone. The findings were presented at the Symposium on Advanced Wound Care Fall 2020 meeting held virtually November 4-6.
The HIFLO trial was a level 1, prospective, single-blind, randomized clinical trial conducted at six sites in the United States that assessed outcomes in 100 patients with Wagner grade 1 and 2 neuropathic diabetic foot ulcers (DFUs). The HIFLO trial’s Principal Investigator is Lisa Gould, MD, Past President of the Wound Healing Society.
According to the company, the patients were randomized 1:1 to SOC or mVasc plus SOC. Investigators used rigorous, prespecified, peer-reviewed criteria to evaluate wound closure, along with blinded independent adjudication by wound care experts. The study also assessed the quality of healing via improvements in perfusion and neuropathy. The primary endpoint was the percentage of ulcers healed within 12 weeks. Additional secondary and research endpoints included wound area percent reduction, time to closure, improvement in perfusion, and peripheral neuropathy.
The study found the following at 12 weeks:
- 74% (37/50) of the mVasc-treated patients’ DFUs were healed versus 38% (19/50) of the SOC-treated patients (P = .00029).
- mVasc treatment increased the odds of healing by 9 times.
- Statistically significant improvements were demonstrated in percent wound area reduction, time to healing, and local neuropathy.
Furthermore, the company noted that improvements in blood flow and regional neuropathy were seen in substudies of mVasc-treated versus SOC-treated patients; however, additional studies will need to be performed to confirm these results in a larger population.
“The HIFLO trial sets a new standard for evaluating advanced wound care tissue therapies,” commented Dr. Gould in the company’s announcement. “This is one of the largest prospective randomized controlled studies of high-risk DFUs. Two key factors in trial design are noteworthy: (1) The trial employed a rigorous definition for wound closure consisting of predefined criteria and confirmation from an independent panel of adjudicators, and (2) a rigorous SOC that included active topical treatment in the control arm. The fact that mVasc significantly outperformed the robust SOC used in this study speaks to the potential of microvascular tissue therapy to benefit this challenging patient population.”