Open AccessImproved healing of chronic diabetic foot wounds in a prospective randomised controlled multi‐centre clinical trial with a microvascular tissue allograft
Author(s) -
Gould Lisa J.,
Orgill Dennis P.,
Armstrong David G.,
Galiano Robert D.,
Glat Paul M.,
Zelen Charles M.,
DiDomenico Lawrence A.,
Carter Marissa J.,
Li William W.
Publication year - 2022
Publication title -
international wound journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.867
H-Index - 63
eISSN - 1742-481X
pISSN - 1742-4801
DOI - 10.1111/iwj.13679
Subject(s) - medicine , wound healing , diabetic foot , clinical endpoint , surgery , wound care , perfusion , clinical trial , diabetic neuropathy , randomized controlled trial , diabetic ulcers , diabetes mellitus , prospective cohort study , endocrinology
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.