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An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial

Aseptically processed human reticular acellular dermal matrix (HR‐ADM) has been previously shown to improve wound closure in 40 diabetic patients with non‐healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire coho...

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Autores principales: Zelen, Charles M, Orgill, Dennis P, Serena, Thomas E, Galiano, Robert E, Carter, Marissa J, DiDomenico, Lawrence A, Keller, Jennifer, Kaufman, Jarrod P, Li, William W
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7949673/
https://www.ncbi.nlm.nih.gov/pubmed/29682897
http://dx.doi.org/10.1111/iwj.12920
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author Zelen, Charles M
Orgill, Dennis P
Serena, Thomas E
Galiano, Robert E
Carter, Marissa J
DiDomenico, Lawrence A
Keller, Jennifer
Kaufman, Jarrod P
Li, William W
author_facet Zelen, Charles M
Orgill, Dennis P
Serena, Thomas E
Galiano, Robert E
Carter, Marissa J
DiDomenico, Lawrence A
Keller, Jennifer
Kaufman, Jarrod P
Li, William W
author_sort Zelen, Charles M
collection PubMed
description Aseptically processed human reticular acellular dermal matrix (HR‐ADM) has been previously shown to improve wound closure in 40 diabetic patients with non‐healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire cohort of 80 patients underwent appropriate offloading and standard of care (SOC) during a 2‐week screening period and, after meeting eligibility criteria, were randomised to receive weekly applications of HR‐ADM plus SOC or SOC alone for up to 12 weeks. The primary outcome was the proportion of wounds closed at 6 weeks. Sixty‐eight percent (27/40) in the HR‐ADM group were completely healed at 6 weeks compared with 15% (6/40) in the SOC group. The proportions of wounds healed at 12 weeks were 80% (34/40) and 30% (12/40), respectively. The mean time to heal within 12 weeks was 38 days for the HR‐ADM group and 72 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any graft‐related adverse events. The mean and median HR‐ADM product costs at 12 weeks were $1200 and $680, respectively. HR‐ADM is clinically superior to SOC, is cost effective relative to other comparable treatment modalities, and is an efficacious treatment for chronic non‐healing diabetic foot ulcers.
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spelling pubmed-79496732021-07-02 An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial Zelen, Charles M Orgill, Dennis P Serena, Thomas E Galiano, Robert E Carter, Marissa J DiDomenico, Lawrence A Keller, Jennifer Kaufman, Jarrod P Li, William W Int Wound J Original Articles Aseptically processed human reticular acellular dermal matrix (HR‐ADM) has been previously shown to improve wound closure in 40 diabetic patients with non‐healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire cohort of 80 patients underwent appropriate offloading and standard of care (SOC) during a 2‐week screening period and, after meeting eligibility criteria, were randomised to receive weekly applications of HR‐ADM plus SOC or SOC alone for up to 12 weeks. The primary outcome was the proportion of wounds closed at 6 weeks. Sixty‐eight percent (27/40) in the HR‐ADM group were completely healed at 6 weeks compared with 15% (6/40) in the SOC group. The proportions of wounds healed at 12 weeks were 80% (34/40) and 30% (12/40), respectively. The mean time to heal within 12 weeks was 38 days for the HR‐ADM group and 72 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any graft‐related adverse events. The mean and median HR‐ADM product costs at 12 weeks were $1200 and $680, respectively. HR‐ADM is clinically superior to SOC, is cost effective relative to other comparable treatment modalities, and is an efficacious treatment for chronic non‐healing diabetic foot ulcers. Blackwell Publishing Ltd 2018-04-22 /pmc/articles/PMC7949673/ /pubmed/29682897 http://dx.doi.org/10.1111/iwj.12920 Text en © 2018 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Zelen, Charles M
Orgill, Dennis P
Serena, Thomas E
Galiano, Robert E
Carter, Marissa J
DiDomenico, Lawrence A
Keller, Jennifer
Kaufman, Jarrod P
Li, William W
An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial
title An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial
title_full An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial
title_fullStr An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial
title_full_unstemmed An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial
title_short An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow‐up trial
title_sort aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: a prospective, randomised, controlled, multicentre follow‐up trial
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7949673/
https://www.ncbi.nlm.nih.gov/pubmed/29682897
http://dx.doi.org/10.1111/iwj.12920
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