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

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, mu...

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Vydané v:	Medicina (Kaunas, Lithuania) Ročník 58; číslo 12; s. 1775
Hlavní autori:	Dardari, Dured, Potier, Louis, Sultan, Ariane, Francois, Maude, M’Bemba, Jocelyne, Bouillet, Benjamin, Chaillous, Lucy, Kessler, Laurence, Carlier, Aurelie, Jalek, Abdulkader, Sbaa, Ayoub, Orlando, Laurent, Bobony, Elise, Detournay, Bruno, Kjartansson, Hilmar, Bjorg Arsaelsdottir, Ragna, Baldursson, Baldur Tumi, Charpentier, Guillaume
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Switzerland MDPI AG 01.12.2022 MDPI
Predmet:	Amputation Animals Biomedical materials Care and treatment cell and/or tissue-based wound care products Clinical trials Debridement Diabetes diabetes foot ulcer Diabetes Mellitus Diabetic foot Diabetic Foot - surgery Diabetic neuropathy Double-Blind Method Double-blind studies Endocrinology and metabolism Fatty acids Fishery products Foot diseases Health aspects Hospitals Human health and pathology Humans intact fish skin graft Ischemia Leg ulcers Life Sciences Mortality Multicenter Studies as Topic Patients Plastic surgery Quality of life Randomized Controlled Trials as Topic Skin & tissue grafts Skin Transplantation Skin-grafting Standard of Care Study Protocol Testing Working groups Wound Healing France diabetes foot ulcer intact fish skin graft cell and/or tissue-based wound care products Diabetes foot ulcer Cell and/or tissue-based wound care products Intact fish skin graft
ISSN:	1648-9144, 1010-660X, 1648-9144
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Popis
Shrnutí:	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.
Bibliografia:	ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Feature-3 ObjectType-Evidence Based Healthcare-1 ObjectType-Undefined-1 content type line 23
ISSN:	1648-9144 1010-660X 1648-9144
DOI:	10.3390/medicina58121775