Abstract
This study assesses the impact of a processed microvascular tissue (PMVT) allograft on wound closure and healing in a prospective, single-blinded, multi-centre, randomised controlled clinical trial of 100 subjects with Wagner Grade 1 and 2 chronic neuropathic diabetic foot ulcerations. In addition to standard wound care, including standardised offloading, the treatment arm received PMVT while the control arm received a collagen alginate dressing. The primary endpoint was complete wound closure at 12 weeks. Secondary endpoints assessed on all subjects were percent wound area reduction, time to healing, and local neuropathy. Novel exploratory sub-studies were conducted for wound area perfusion and changes in regional neuropathy. Weekly application of PMVT resulted in increased complete wound closure at 12 weeks (74% vs 38%; P =.0003), greater percent wound area reduction from weeks four through 12 (76% vs 24%; P =.009), decreased time to healing (54 days vs 64 days; P =.009), and improved local neuropathy (118% vs 11%; P =.028) compared with the control arm. Enhanced perfusion and improved regional neuropathy were demonstrated in the sub-studies. In conclusion, this study demonstrated increased complete healing with PMVT and supports its use in treating non-healing DFUs. The observed benefit of PMVT on the exploratory regional neuropathy and perfusion endpoints warrants further study.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 811-825 |
| Number of pages | 15 |
| Journal | International Wound Journal |
| Volume | 19 |
| Issue number | 4 |
| DOIs | |
| State | Published - May 2022 |
Funding
The authors wish to acknowledge Nathan Young (Foot & Ankle Associates of Southwest Virginia), Allen Jacobs (SSM Health), and Rachel Hoyal (Sutter Health) for participation as clinical study investigators; Tracey Ikerd (Riverview Health), Jonathan Arnold (Mercy Healing Center), and John Lindberg (Emanate Health) for fluorescence angiography analysis and expertise; Travis Smith and Emmanuel Wilson (eKare, Inc.) for wound measurement system support; Morgan Stepanek and Kim Young (PERI, Inc.) for clinical study support; Douglas M. Arm (MicroVascular Tissues, Inc.) for assistance with study design, clinical study support, data analysis, and manuscript review/editing; and Valerie L. Marmolejo (Scriptum Medica) for assistance with manuscript preparation. L.G. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The HIFLO Trial was sponsored by MicroVascular Tissues, Inc. (San Diego, CA). The authors wish to acknowledge Nathan Young (Foot & Ankle Associates of Southwest Virginia), Allen Jacobs (SSM Health), and Rachel Hoyal (Sutter Health) for participation as clinical study investigators; Tracey Ikerd (Riverview Health), Jonathan Arnold (Mercy Healing Center), and John Lindberg (Emanate Health) for fluorescence angiography analysis and expertise; Travis Smith and Emmanuel Wilson (eKare, Inc.) for wound measurement system support; Morgan Stepanek and Kim Young (PERI, Inc.) for clinical study support; Douglas M. Arm (MicroVascular Tissues, Inc.) for assistance with study design, clinical study support, data analysis, and manuscript review/editing; and Valerie L. Marmolejo (Scriptum Medica) for assistance with manuscript preparation. L.G. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The HIFLO Trial was sponsored by MicroVascular Tissues, Inc. (San Diego, CA).
Keywords
- angiogenesis
- diabetic foot ulcer
- microvasculature/microvascular tissue
- peripheral neuropathy
- wound healing
ASJC Scopus subject areas
- Surgery
- Dermatology
