Diabetic Foot Unit, Centre Hospitalier sud Francilien Corbeil Essonnes, 91100 Corbeil-Essonnes, France.
LBEPS, IRBA, Université Evry Paris Saclay, 91025 Evry, France.
Medicina (Kaunas). 2022 Dec 1;58(12):1775. doi: 10.3390/medicina58121775.
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.
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.
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.
基于细胞和/或组织的伤口护理产品在治疗难愈性溃疡方面已经取得了缓慢的进展，然而，很少有研究评估这些设备在管理严重糖尿病足溃疡方面的有效性。
本研究（KereFish）是一项多中心、随机、对照临床试验（Odin）的一部分，纳入患有深部糖尿病伤口的患者，允许存在外周动脉疾病，踝肱指数评估值等于或高于 0.6。该研究设有平行的治疗组：第 1 组使用 Kerecis Omega3 Wound™治疗，第 2 组使用标准护理治疗。主要目的是检验以下假设：与标准护理相比，使用 Kerecis Omega3 Wound™治疗将有更多数量的严重糖尿病溃疡和截肢伤口（包括那些有中度动脉疾病的伤口）在 16 周内愈合。
本研究已获得每个参与国家的伦理委员会批准。参与者的纳入始于 2020 年 3 月，于 2022 年 7 月结束。第一批结果将于 2023 年 3 月公布。该研究在 ClinicalTrials.gov 注册，标识符为 NCT04537520。
