A Randomized, Controlled Multicenter Clinical Trial of a Novel Processed Microvascular Tissue Graft: Wound Closure and Enhanced Tissue Quality in Nonhealing Diabetic Neuropathic Foot Ulcers
INTRODUCTION: Processed microvascular tissue (PMVT*), comprised of a minimally manipulated vascular bed, enhances angiogenesis and wound healing preclinically, and in clinical case series heals complex wounds and chronic diabetic foot ulcers.1-6 We present the results of a randomized, controlled, multicenter clinical trial (n=100 patients with nonhealing Wagner 1-2 DFUs) to assess patient outcomes following PMVT treatment.
METHODS: Patients with diabetic lower extremity wounds that have been present for ³4 weeks were eligible for enrollment. Screening included a 2-week run-in period with standard of care (SOC) treatment (sharp debridement, topical collagen and nonadherent dressings, offloading) that excluded patients if the wound area decreased >20%. Patients were randomized 1:1 to receive either SOC, or SOC plus weekly topical application of PMVT instead of collagen.
Index wounds were measured weekly using an infrared imaging system. Wound closure was evaluated by the treating investigator, and verified by an independent clinician and a panel of blinded adjudicators employing pre-specified closure criteria.7 The primary endpoint was percentage of ulcers healed at 12 weeks. Secondary endpoints were percent wound area reduction, infection, WQOL, and peripheral neuropathy. Fluorescence microangiography was performed to assess wound perfusion.
RESULTS: Planned interim analysis (n=53 patients) showed 70% ulcer closure with PMVT within 12 weeks compared to SOC (29%), which translates to a statistical power of 99.5% based upon 100 patients. PMVT percent area reduction was 70.4% vs. 33.4% SOC (6 weeks); and 83.4% vs. 36.8% SOC (12 weeks). Remarkably, PMVT treatment increased the Semmes-Weinstein score by 42-fold (1.7±3.0 vs. 0.04±1.3). Neuropathy improvement was further documented by stocking-glove area analysis (n=21) with PMVT (64.2%) > SOC (15.7%). The final results (n=100) including perfusion, quality of healing, and health economic outcomes will be presented.
CONCLUSION: Weekly application of PMVT safely closed wounds and reduced wound area faster than SOC, and notably, reversed diabetic neuropathy.
Trademarked Items (if applicable): *mVASC® – MicroVascular Tissues, Inc., San Diego, CA
References (if applicable): 1) Peterson DR, et al., SAWC Spring, LB-050 (2018).
2) Peterson DR, et al., SAWC Spring, LB-049 (2018).
3) Gimble JM, et al., Plastic and Reconstructive Surgery – Global Open, 6(11):e2010 (2018).
4) Dobke M, et al., Regen Med, 15(2):1313 (2020).
5) Zelen CM, et al., Wounds, 31(4):E29 (2019).
6) Dobke M, et al., SAWC Spring, CS-018 (2019).
7) Gould L, Li WW, Wound Repair and Regeneration, 27(3):201 (2019).
