Allograft Tackles a Microvascular Problem With a Microvascular Solution

Although complete closure is important in treating diabetic foot ulcers (DFU), an equally vital component of healing is to address the impaired vasculature that led to non-healing of the DFU. An innovative tissue allograft sourced from microvascular tissues may address that impaired vasculature.

The mVASC allograft is the first microvascular therapy based on a microvascular tissue allograft that can heal a DFU by increasing local blood flow, which results in wound closure and decreased neuropathy, according to manufacturer MicroVascular Tissues (MVT). The company notes mVASC may help improve tissue function and reduce associated complications.

One advantage of the mVASC tissue allograft is that it is sourced directly from microvascular tissues and is not a covering like skin, placental, or umbilical tissue, notes Lawrence DiDomenico, DPM. He says its composition of microvessel fragments and extracellular matrix elements serves as a foundation to help restore the microcirculatory blood flow in and around the wound bed.

Dr. DiDomenico was one of the investigators in MicroVascular Tissues’ randomized controlled clinical trial assessing mVASC in 50 patients with nonhealing Wagner grades 1 and 2 neuropathic diabetic foot ulcers, compared to 50 control patients.¹ The primary endpoint in the study was complete wound closure at 12 weeks, while the secondary endpoints assessed on all patients were percent of wound area reduction, time to healing, and local neuropathy. Researchers found weekly application of mVASC resulted in increased complete wound closure at 12 weeks, greater percent of wound area reduction from weeks 4 through 12, decreased time to healing (54 days vs 64 days), and improved local neuropathy (118% vs 11%) compared with the control arm. The study adds that enhanced wound-area tissue perfusion and improved regional neuropathy were demonstrated in the sub-studies.

Dr. DiDomenico found mVASC “very successful” in closing these wounds. “Based on what I’ve seen, I believe mVASC could be effective in other applications where the microvasculature is compromised,” he notes.

As MicroVascular Tissues notes, processing mVASC produces a sterile, dehydrated disk composed of microvascular tissue fragments. The allograft is ready for use off the shelf and will be stable for 5 years when stored at room temperature. One would apply the dry mVASC disk directly to the wound bed and cover the disk with a non-adherent dressing. The company notes the local bleeding following debridement hydrates the mVASC disk, and microvascular fragments disperse readily into the wound bed.

As Dr. DiDomenico says, one advantage of mVASC is that it directly addresses a microvascular problem with a microvascular solution, which he notes is unique. The RCT demonstrated increased healing and closure rates with mVASC, as well as improved tissue quality in sub-group analyses. In these sub-studies, Dr. DiDomenico and colleagues observed increased blood flow compared to the control (standard of care) patients, and mVASC treatment also led to a surprising improvement in peripheral neuropathy.

“Despite the current advanced wound care product offerings, many ulcers still do not close quickly, or at all. As everyone is aware, the longer an ulcer stays open, the more likely other complications will occur,” says Dr. DiDomenico. “mVASC is another tool in my toolkit which I can now use to address my hard-to-heal wound patients with microvascular deficiencies.”

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Reference

1. Gould LJ, Orgill DP, Armstrong DG, et al. Improved healing of chronic diabetic foot wounds in a prospective randomised controlled multi-centre clinical trial with a microvascular tissue allograft. Int Wound J. 2021; epub Sept. 1.