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A Feasibility and Safety Study of a Novel Human Decellularized Dermal Matrix to Accelerate Healing of Neuropathic Diabetic Foot Ulcers in People With Type 1 and Type 2 Diabetes

Published:April 06, 2022DOI:https://doi.org/10.1016/j.jcjd.2022.03.010

      Abstract

      Objectives

      The purpose of this study was to determine the feasibility and safety of a novel decellularized dermal matrix (DDM) for the treatment of chronic diabetic foot ulcers (DFUs).

      Methods

      An interventional, single-arm, prospective study of DDM for DFU treatment was conducted in 2 Canadian centres from July 1, 2016, to May 30, 2017. Individuals ≥18 years of age with an active DFU of ≥2 weeks and ulcer area ≥1 cm2 before debridement and who consented to participate were enrolled in this clinical trial.

      Results

      A total of 11 patients were enrolled, with 9 patients (82%) having achieved 100% closure between 2 and 8 weeks. The mean and median times to wound closure for these patients were 3.3 and 2.5 weeks, respectively. The mean and median reductions in wound area at 4 weeks posttreatment were 87% and 100%, respectively. The proportion of patients having achieved complete healing at 12 weeks was 82%. All patients received only 1 DDM application to achieve these results. There were no adverse events related to use of the product. No cases of recurrence during a 1-year follow-up after completion of the study were reported for patients who achieved wound closure.

      Conclusions

      These findings provide evidence that this DDM may be safe and effective for the treatment of chronic, hard-to-heal neuropathic DFUs. Specifically, DDM demonstrated the potential to accelerate healing of DFUs when compared with reported times of 8 to 12 weeks required to achieve closure using the current standard of care.

      RÉSUMÉ

      Objectifs

      L’objectif de la présente étude était de déterminer la faisabilité et l’innocuité de la nouvelle matrice dermique décellularisée (MDD) dans le traitement des ulcères chroniques du pied diabétique (UPD).

      Méthodes

      Nous avons mené une étude prospective interventionnelle à volet unique sur la MDD dans le traitement des UPD dans 2 établissements canadiens du 1er juillet 2016 au 30 mai 2017. Nous avons inscrit à cette étude clinique les individus de ≥ 18 ans, qui avaient un UPD actif depuis ≥ 2 semaines, dont la surface était de ≥ 1 cm2 avant le débridement, et qui consentaient à participer à l’étude.

      Résultats

      Nous avons inscrit un total de 11 patients, dont 9 (82 %) avaient vu leur plaie se refermer à 100 % entre 2 et 8 semaines. Les temps moyen et médian de la fermeture de la plaie de ces patients étaient respectivement de 3,3 et de 2,5 semaines. Les réductions moyenne et médiane de la surface de la plaie 4 semaines après le traitement étaient respectivement de 87 % et de 100 %. Le pourcentage de patients qui avaient eu une guérison complète après 12 semaines était de 82 %. Tous les patients ont reçu 1 seule application de MDD pour obtenir ces résultats. Il n’y a eu aucun événement indésirable associé à l’utilisation du produit. Aucun cas de récidive n’a été signalé jusqu’à 1 an après la fin de l’étude chez les patients dont la plaie s’était refermée.

      Conclusions

      Ces résultats montrent l’innocuité et l’efficacité de cette MDD dans le traitement des UPD neuropathiques chroniques difficiles à guérir. Particulièrement, la MDD a démontré son potentiel à accélérer la guérison des UPD lorsqu’on la compare aux normes actuelles en matière de soins qui requièrent de 8 à 12 semaines pour parvenir à la fermeture de la plaie.

      Keywords

      Mots clés

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