Article Dans Une Revue International Wound Journal Année : 2026

Intent to Treat Analysis of the Primary and Secondary Outcomes for the ODINN Intact Fish Skin Graft for Deep Diabetic Foot Wounds Trial.

1 CHSF - Centre Hospitalier Sud Francilien - Centre Hospitalier d'Evry
2 LBEPS - Laboratoire de Biologie de l'Exercice pour la Performance et la Santé
3 IRBA - Institut de Recherche Biomédicale des Armées [Brétigny-sur-Orge]
4 PUH - Ospedaliero Universitaria Pisana = Pisa University Hospital [Pisa]
5 Service d'endocrinologie, diabétologie et nutrition [CHU Bichat]
6 INEM - UM 111 (UMR 8253 / U1151) - Institut Necker Enfants-Malades
7 PhyMedExp - Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
8 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
9 Krankenhaus Buchholz und Winsen gGmbH/Buchholz and Winsen Hospital gGmbH [Buchholz, Germany]
10 CHU Reims - Hôpital universitaire Robert Debré [Reims]
11 Universität zu Köln = University of Cologne
12 University Hospital of Cologne [Cologne]
13 Service d'Endocrinologie, Diabétologie et Maladies Métaboliques (CHU de Dijon)
14 CTM - Center for Translational and Molecular medicine [Dijon - UMR1231]
15 Service de diabétologie [CHU Cochin]
16 ITX-lab - ITX-lab unité de recherche de l'institut du thorax UMR1087 UMR6291
17 CSC - Clinica San Carlo [Milan, Italy]
18 Nouvel Hôpital Civil de Strasbourg
19 Wertachkliniken/Wertach Clinics [Munich, Germany]
20 SKK/KMH - Städtisches Klinikum Karlsruhe/Karlsruhe Municipal Hospital [Karlsruhe, Germany]
21 IC - Independent Cosultant [Minneapolis, Minnesota, USA]
22 ISC - Inpendent Statistical Consultants [Copenhagen, Denmark]
23 Landspitali National University Hospital of Iceland
24 CERITD - Centre d'études et de recherches pour l'intensification du traitement du diabète
25 MSSM - Icahn School of Medicine at Mount Sinai [New York]

Résumé

There is a significant need for trials that evaluate the treatment of University of Texas (UT) grade 2 and 3 diabetic foot ulcers (bone, joint, or tendon exposed wounds). We undertook a trial looking at the effect of intact fish skin graft (IFSG) on these deep and difficult-to-heal ulcers. 262 patients Intent to Treat (ITT) patients with UT grade 2 and 3 DFUs were randomised to receive intact fish skin graft (IFSG) or a standardised treatment (SOC) that adhered to the International Working Group on the Diabetic Foot (IWGDF) guidelines. The secondary endpoints that were measured included wound area reduction (WAR), healing rates at 20 and 24 weeks; closure rates by UT grade, perfusion, quality of life, pain reduction and IFSG safety. We report ITT (all randomised) (mITT previosly reported) The (WAR) at 12 weeks was 65.53% for IFSG versus 30.82% for SOC (p = 0.007). UT 2 wounds (60% of total) exhibited a closure rate of 47% versus 23% at 16 weeks for IFSG versus SOC (p = 0.0033). Target wound infections were comparable (39 vs. 37) and major outcomes were comparable during the 24 week period (target-limb amputations 8% vs. 7%). Time-to-heal favoured IFSG (restricted mean to 24 weeks 17.31 vs. 19.37 weeks; KM/log-rank significant; Cox HR 1.59). The in the treatment of deep complex diabetic foot wounds the addition of IFSG significantly improved the number of patients with total wound closure as well as the time to wound closure without increased risk of complications. This improvement in total wound closure and time to wound closure was noted across prior amputation status, quality of perfusion, and UT grade.

Dates et versions

hal-05540699 , version 1 (06-03-2026)

Identifiants

Citer

Dured Dardari, Alberto Piaggesi, Louis Potier, Ariane Sultan, Holger Diener, et al.. Intent to Treat Analysis of the Primary and Secondary Outcomes for the ODINN Intact Fish Skin Graft for Deep Diabetic Foot Wounds Trial.. International Wound Journal, 2026, 23 (3), pp.e70847. ⟨10.1111/iwj.70847⟩. ⟨hal-05540699⟩
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