Logo image
Back
Multi-centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers
Journal article   Open access   Peer reviewed

Multi-centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers

David G Armstrong, Robert D Galiano, Dennis P Orgill, Paul M Glat, Marissa J Carter, Lawrence A Di Domenico, Alexander M Reyzelman and Charles M Zelen
International wound journal, v 19(4), pp 932-944
May 2022
DOI: https://doi.org/10.1111/iwj.13759
PMID: 35080127
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.1111/iwj.13759View
Published, Version of Record (VoR)CC BY-NC-ND V4.0,  Open

Abstract

Allografts Blood Glucose Blood Glucose Self-Monitoring Diabetes Mellitus Diabetic Foot - surgery Humans Prospective Studies Quality of Life Standard of Care Treatment Outcome
Diabetic foot ulcers (DFUs) pose a significant risk for infection and limb loss. Advanced wound therapies including human skin allografts have shown promise in resolving these challenging wounds. The primary objective of this randomised, prospective study was to compare the response of 100 subjects with non-healing DFUs of which 50 were treated with a cryopreserved bioactive split thickness skin allograft (BSA) (TheraSkin; Misonix,Inc., Farmingdale, NY) compared with 50 subjects treated with standard of care (SOC, collagen alginate dressing) at 12 weeks. Both groups received standardised care that included glucose monitoring, weekly debridement's as appropriate, and an offloading device. The primary endpoint was proportion of full-thickness wounds healed at 12 weeks, with secondary endpoints including differences in percent area reduction (PAR) at 12 weeks, changes in Semmes-Weinstein monofilament score, VAS pain, and w-QoL. The result illustrated in the intent-to-treat analysis at 12 weeks showed that 76% (38/50) of the BSA-treated DFUs healed compared with 36% (18/50) treated with SOC alone (adjusted P = .00056). Mean PAR at 12 weeks was 77.8% in the BSA group compared with 49.6% in the SOC group (adjusted P = .0019). In conclusion, adding BSA to SOC appeared to significantly improve wound healing with a lower incidence of adverse events related to treatment compared with SOC alone.

Metrics

7 Record Views
18 citations in Web of Science
16 citations in Scopus

Details

UN Sustainable Development Goals (SDGs)

This publication has contributed to the advancement of the following goals:

#3 Good Health and Well-Being

InCites Highlights

Data related to this publication, from InCites Benchmarking & Analytics tool:

Collaboration types
Domestic collaboration
Web of Science research areas
Dermatology
Surgery
Logo image