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The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi‐centre, controlled, randomised, blinded, clinical trial

In a randomised, controlled study, we compared the efficacy of Grafix(®), a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints...

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Autores principales: Lavery, Lawrence A, Fulmer, James, Shebetka, Karry Ann, Regulski, Matthew, Vayser, Dean, Fried, David, Kashefsky, Howard, Owings, Tammy M, Nadarajah, Janaki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951030/
https://www.ncbi.nlm.nih.gov/pubmed/25048468
http://dx.doi.org/10.1111/iwj.12329
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author Lavery, Lawrence A
Fulmer, James
Shebetka, Karry Ann
Regulski, Matthew
Vayser, Dean
Fried, David
Kashefsky, Howard
Owings, Tammy M
Nadarajah, Janaki
author_facet Lavery, Lawrence A
Fulmer, James
Shebetka, Karry Ann
Regulski, Matthew
Vayser, Dean
Fried, David
Kashefsky, Howard
Owings, Tammy M
Nadarajah, Janaki
author_sort Lavery, Lawrence A
collection PubMed
description In a randomised, controlled study, we compared the efficacy of Grafix(®), a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0·0001). The median time to healing was 42 days in Grafix patients compared with 69·5 days in controls (P = 0·019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0·031) and fewer Grafix patients with wound‐related infections (18% versus 36·2%, P = 0·044). Among the study subjects that healed, ulcers remained closed in 82·1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0·419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU‐related complications. The results of this well‐controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy.
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spelling pubmed-79510302021-07-02 The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi‐centre, controlled, randomised, blinded, clinical trial Lavery, Lawrence A Fulmer, James Shebetka, Karry Ann Regulski, Matthew Vayser, Dean Fried, David Kashefsky, Howard Owings, Tammy M Nadarajah, Janaki Int Wound J Original Articles In a randomised, controlled study, we compared the efficacy of Grafix(®), a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0·0001). The median time to healing was 42 days in Grafix patients compared with 69·5 days in controls (P = 0·019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0·031) and fewer Grafix patients with wound‐related infections (18% versus 36·2%, P = 0·044). Among the study subjects that healed, ulcers remained closed in 82·1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0·419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU‐related complications. The results of this well‐controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy. Blackwell Publishing Ltd 2014-07-21 /pmc/articles/PMC7951030/ /pubmed/25048468 http://dx.doi.org/10.1111/iwj.12329 Text en © 2014 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/3.0/ 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
Lavery, Lawrence A
Fulmer, James
Shebetka, Karry Ann
Regulski, Matthew
Vayser, Dean
Fried, David
Kashefsky, Howard
Owings, Tammy M
Nadarajah, Janaki
The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi‐centre, controlled, randomised, blinded, clinical trial
title The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi‐centre, controlled, randomised, blinded, clinical trial
title_full The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi‐centre, controlled, randomised, blinded, clinical trial
title_fullStr The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi‐centre, controlled, randomised, blinded, clinical trial
title_full_unstemmed The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi‐centre, controlled, randomised, blinded, clinical trial
title_short The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi‐centre, controlled, randomised, blinded, clinical trial
title_sort efficacy and safety of grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi‐centre, controlled, randomised, blinded, clinical trial
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951030/
https://www.ncbi.nlm.nih.gov/pubmed/25048468
http://dx.doi.org/10.1111/iwj.12329
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