SLR - July 2022 - Stephanie Ragan
References: Gould Lisa, Orgill Denis, Armstrong David G, Galiano Robert D, Glat Paul M, Zelen Charles M, DiDomenico Lawrence A, Carter Marissa J, Li William W. Improved healing of chronic diabetic foot wounds in a prospective randomized controlled multi-centre clinical trial with a microvascular tissue allograft. International Wound Journal. 2022;19:811-825Level of evidence: 2
Scientific Literature Review
Reviewed by: Stephanie Ragan
Residency Program: Hennepin HealthCare
Podiatric Relevance:
Diabetic foot ulcerations are the most common injury leading to amputation in the lower extremity. Non-healing or slow healing wounds are at an increased risk for getting infected. There are many different products available on the market to decrease time to healing and decrease wound area. One of the newer products on the market is processed microvascular tissue (PMVT) which is a structural allograft consisting of microvascular tissue fragments harvested from nondiabetic donors less than 65 years of age. This study aimed to compare wound healing in diabetic wounds treated with PMVT allograft vs collagen alginate dressing. The primary end point was complete wound closure at 12 weeks and secondary endpoints were percent wound area reduction at 4,6,7 and 12 weeks, time to healing and local neuropathy.
Methods:
This was a prospective, single-blinded, multi-center, randomized controlled clinical trial of 100 patients with Wagner Grade 1 and 2 diabetic foot ulcerations. Patients were randomly split into two groups with 50 patients in each group. Patients were seen weekly, underwent cleansing and debridement as indicated. Patients then received a primary dressing of a collagen calcium alginate dressing or a PMVT dressing followed by a three-layer dressing with felt padding and DARCO CAM boot. Patients’ wounds were measured weekly using a 3D digital infrared imaging technology system. Local peripheral neuropathy was recorded each week using a monofilament. Confirmation of wound closure was performed by an independent investigator, a separate blinded physician at the study site who had not been treating the wound, and a panel of three independent blind adjudicators with expertise in wound care.
Results:
Patients who received PMVT had a statistically significant increase in the percentage of wounds closed at 12 weeks. Seventy-four (74) percent PMVT ulcerations were completely closed at 12 weeks while only 38 percent of the control group were completely closed. The average time to healing in the control group was 64 days and in the PMVT group was 54 days which was also statistically significant. There was also improvement in peripheral neuropathy at the end of treatment in the PMVT group compared to the control.
Conclusions:
The authors concluded that weekly applications of PMVT showed significantly greater wound closure, faster time to wound healing and decrease in peripheral neuropathy compared to the control group. I agree that for nonhealing or slow healing diabetic ulcerations, PMVT could be a good option to assist podiatrists in wound closure. However, one must also be cognizant of other factors that could be affecting wound healing such as increased pressure and vascular status. Another factor to keep in mind would be cost of the grafts compared to collagen grafts. It would be interesting to see future studies comparing this graft vs other ones currently on the market. It is important to note that this study was funded by MicroVascular Tissues Inc.