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

Publisher Copyright: © 2022 by the authors.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.Peer reviewe

Évaluation de deux programmes d’éducation thérapeutique du patient sur la prévention des plaies de pieds diabétiques à risques

International audienceObjectives: The purpose of this study is to evaluate and compare the effects of two education programs on patients' understanding of the disease, self-efficacy, locus of control, and application of prevention behaviors for foot ulcer. Methods: In four centers that manage patients with diabetes and grade 2 or 3 neuropathy, the first arm of patients (G1 = 53) participated in a "standard" program usually managed in each center, and those in the second arm (G2 = 56) in a "new" program. The patients completed four questionnaires at inclusion (T0) and six months after the education (T1). Occurrence of a new foot ulcer and care behaviors were collected at T1. Z-test was used to compare mean scores for each questionnaire and Fisher's exact test for percentages (p = 0.05). Results: There was no significant difference between groups G1 and G2 in terms of scores for each questionnaire at T0 and T1. Group G2 showed a significant change in score between T0 and T1 for understanding the disease (p = 0.04) and prevention behaviors (p = 0.01). For the sample as a whole (n = 109), there was a significant improvement between T0 and T1 for two questionnaires: understanding of disease (p < 0.01) and declared prevention behaviors (p < 0.01). Patients who reported having relative to participate in care had a significantly higher mean score on prevention behaviors (p < 0.01). Twenty patients had developed one new ulcer since the education (20.2%). Conclusion: This study reinforces the importance of devoting time during education to patients' understanding of the disease and involving relatives to improve foot ulcer prevention behaviors.Évaluation de deux programmes d'éducation thérapeutique du patient sur la prévention des plaies de pieds diabétiques à risques. Objectif : Le but de cette étude est d'évaluer et de comparer les effets de deux programmes d'éducation sur la compréhension de la maladie par les patients, l'auto efficacité, le locus de contrôle et l'application des comportements de prévention de l'ulcère du pied. Méthode : Dans quatre centres de référence pour les patients atteints de diabète avec une neuropathie de grade 2 ou 3, le premier groupe de patients (G1 = 53) a participé à un programme "standard" habituellement utilisé dans chaque centre, et ceux du deuxième groupe (G2 = 56) à un "nouveau" programme. Les patients ont rempli quatre questionnaires à l'inclusion (T0) et six mois après l'éducation (T1). L'apparition d'un nouvel ulcère du pied et d'autres comportements de prévention ont été notés à T1. Le test Z a été utilisé pour comparer les résultats moyens de chaque questionnaire et le test exact de Fisher pour les pourcentages (p = 0,05). Résultats : Il n'y avait pas de différence significative entre les groupes G1 et G2 concernant les résultats de chaque questionnaire à T0 et T1. Le groupe G2 a montré un changement significatif dans le score entre T0 et T1 pour deux questionnaires : compréhension de la maladie (p < 0,01) et des comportements de prévention déclarés (p < 0,01). Les patients qui ont déclaré avoir un proche participant aux soins ont obtenu un score moyen significativement plus élevé pour les comportements de prévention (p < 0,01). Vingt patients avaient développé un nouvel ulcère depuis l’éducation (20,2 %). Conclusion : Cette étude souligne l’importance de consacrer du temps à la compréhension de la maladie par les patients et d’impliquer les proches dans l’amélioration des comportements de prévention des ulcères du pied

Trends in the relation between hyperglycemia correction and active Charcot neuroarthropathy: results from the EPICHAR study

International audienceIntroduction The pathophysiology of Charcot neuroarthropathy (CN) remains unclear. There are a number of hypotheses but these are not exclusive. In its clinical presentation, this complication intersects with the semiology of diabetic-induced neuropathy, such as peripheral hypervascularization and the appearance of arteriovenous shunt. The EPICHAR study is as yet an unpublished cohort of people living with diabetes complicated by CN (in active or chronic phase). Based on the findings of the EPICHAR study, this study aimed to investigate whether a reduction in the rate of hyperglycemia accompanies the onset of an active phase of CN.Research design and methods Hemoglobin A1c (HbA1c) levels were assessed 3 months (M3) and 6 months (M6) before the diagnosis of active CN (M0).Results 103 patients living with diabetes and presenting active CN were included between January and December 2019 from the 31 centers participating in this study (30 in France and 1 in Belgium). The mean age of the participants was 60.2±12.2 years; the vast majority were men (71.8%) living with type 2 diabetes (75.5%). Mean HbA1c levels significantly declined between M6 (median 7.70; Q1, Q3: 7.00, 8.55) and M3 (median 7.65; Q1, Q3: 6.90, 8.50) (p=0.012), as well as between M6 and M0 (median 7.40; Q1, Q3: 6.50, 8.50) (p=0.014). No significant difference was found between M3 and M0 (p=0.072).Conclusions A significant reduction in HbA1c levels seems to accompany the onset of the active phase of CN. Trial registration number NCM03744039