Files and links (1)
Published, Version of Record (VoR)CC BY-NC-ND V4.0, Open
Journal article
Improved healing of chronic diabetic foot wounds in a prospective randomised controlled multi-centre clinical trial with a microvascular tissue allograft
International wound journal, v 19(4), pp 811-825
01 May 2022
PMID: 34469077
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.
Metrics
Details
- Title
- Improved healing of chronic diabetic foot wounds in a prospective randomised controlled multi-centre clinical trial with a microvascular tissue allograft
- Creators
- Lisa J. Gould - South Shore HospitalDennis P. Orgill - Professional Education and Research InstituteDavid G. Armstrong - Keck Hospital of USCRobert D. Galiano - Northwestern MedicinePaul M. Glat - Drexel UniversityCharles M. Zelen - Professional Education and Research InstituteLawrence A. DiDomenico - Orthopedic Foot & Ankle CenterMarissa J. Carter - Strategic Solutions, Inc., Bozeman, Montana, USA.William W. Li - Angiogenesis Foundation
- Publication Details
- International wound journal, v 19(4), pp 811-825
- Publisher
- Wiley
- Number of pages
- 15
- Grant note
- MicroVascular Tissues, Inc.
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:000691703000001
- Scopus ID
- 2-s2.0-85114052703
- Other Identifier
- 991019168002004721
UN Sustainable Development Goals (SDGs)
This publication has contributed to the advancement of the following goals:
InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Dermatology
- Surgery