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.

Aims During the Covid‐19 epidemic, many countries imposed population lockdown. This study aimed to analyse diabetic foot ulcer (DFU) evolution of outpatients between the lockdown period and 1 month after its end. Materials and Methods We conducted a prospective, observational, single‐centre study without modification of care. All patients who followed up for a DFU in the study centre between 15 April 2020 and 11 May 2020 were included. The baseline assessment occurred 4 weeks after the beginning of lockdown and the follow‐up visit 4–6 weeks after easing of lockdown. The primary analysis was based on the Site, Ischaemia, Neuropathy, Bacterial infection, Area, Depth (SINBAD) classification. Results Twenty‐seven patients were included, median 69.4 years, and 25 were followed‐up at easing of lockdown. The median SINBAD score was 2 (interquartile range 1; 3) at inclusion and 1 (1; 2) at easing of lockdown, with a mean change of −0.32 (95% confidence interval −0.93; 0.29). Seventy‐two percent of the population had a stable or improved score between the two visits. The proportion of patients using off‐loading footwear was higher among those whose SINBAD score improved compared to those whose score worsened or remained stable (72%, 44% and 28%, respectively). Diabetes type was linked to DFU prognosis. Five patients (20%) were hospitalized during the follow‐up period. Conclusion Lockdown appears to have had a positive effect on DFU if patients remain under the care of their expert wound centre. We believe this effect is related to better compliance with offloading. The wide use of tele‐medicine seems relevant for the follow‐up of DFU.

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