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Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study) : An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale

Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study) : An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale


Title: Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study) : An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale
Author: Dardari, Dured
Potier, Louis
Sultan, Ariane
Francois, Maude
M’Bemba, Jocelyne
Bouillet, Benjamin
Chaillous, Lucy
Kessler, Laurence
Carlier, Aurelie
Jalek, Abdulkader
... 8 more authors Show all authors
Date: 2022-12
Language: English
Scope: 367528
Department: Other departments
Series: Medicina (Lithuania); 58(12)
ISSN: 1010-660X
DOI: 10.3390/medicina58121775
Subject: Bráðalæknisfræði; Húð-og kynsjúkdómalæknisfræði; cell and/or tissue-based wound care products; diabetes foot ulcer; intact fish skin graft; Medicine (all)
URI: https://hdl.handle.net/20.500.11815/4027

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Citation:

Dardari , D , Potier , L , Sultan , A , Francois , M , M’Bemba , J , Bouillet , B , Chaillous , L , Kessler , L , Carlier , A , Jalek , A , Sbaa , A , Orlando , L , Bobony , E , Detournay , B , Kjartansson , H , Bjorg Arsaelsdottir , R , Baldursson , B T & Charpentier , G 2022 , ' Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study) : An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale ' , Medicina (Lithuania) , vol. 58 , no. 12 , 1775 . https://doi.org/10.3390/medicina58121775

Abstract:

Background: Cell and/or tissue-based wound care products have slowly advanced in the treatment of non-healing ulcers, however, few studies have evaluated the effectiveness of these devices in the management of severe diabetic foot ulcers. Method: This study (KereFish) is part of a multi-national, multi-centre, randomised, controlled clinical investigation (Odin) with patients suffering from deep diabetic wounds, allowing peripheral artery disease as evaluated by an ankle brachial index equal or higher than 0.6. The study has parallel treatment groups: Group 1 treatment with Kerecis® Omega3 Wound™ versus Group 2 treatment with standard of care. The primary objective is to test the hypothesis that a larger number of severe diabetic ulcers and amputation wounds, including those with moderate arterial disease, will heal in 16 weeks when treated with Kerecis® Omega3 Wound™ than with standard of care. Conclusion: This study has received the ethics committee approval of each participating country. Inclusion of participants began in March 2020 and ended in July 2022. The first results will be presented in March 2023. The study is registered in ClinicalTrials.gov as Identifier: NCT04537520.

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Publisher Copyright: © 2022 by the authors.

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