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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Article Info
Publication History
Published online: April 06, 2022
Accepted:
March 29,
2022
Received in revised form:
February 9,
2022
Received:
July 15,
2021
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2022 Canadian Diabetes Association.
