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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References
- Global estimates of diabetes prevalence for 2013 and projections for 2035.Diabetes Res Clin Prac. 2014; 103: 137-149
- New diabetes rates released with urgent plea for governments to implement national diabetes strategy. 2019.https://www.diabetes.ca/media-room/press-releases/new-diabetes-rates-released-with-urgent-plea-for-governments-to-implement-national-diabetes-strategyDate: 2021Date accessed: February 19, 2021
- Preventing foot ulcers in patients with diabetes.JAMA. 2005; 293: 217-228
- The global burden of diabetic foot disease.Lancet. 2005; 366: 1719-1724
- Update on management of diabetic foot ulcers.Ann NY Acad Sci. 2018; 1411: 153-165
- The epidemiology of diabetic foot problems.Diabet Med. 1996; 13: S6-S11
- Mortality rates and diabetic foot ulcers: Is it time to communicate mortality risk to patients with diabetic foot ulceration?.J Am Podiatr Med Assoc. 2008; 98: 489-493
- Relative survival: Cancer care Ontario.https://www.cancercareontario.ca/sites/ccocancercare/files/assets/ocschapterfour.pdfDate accessed: March 1, 2021
- Audit of time taken to heal diabetic foot ulcers.Practical Diabetes Int. 2001; 18: 6-9
- Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial.Diabetes Care. 2003; 26: 1879-1882
- Wound healing outcomes in a diabetic foot ulcer outpatient clinic at an acute care hospital: A retrospective study.J Wound Care. 2017; 26: S4-S11
- Burden of infected diabetic foot ulcers on hospital admissions and costs.Ann Vasc Surg. 2016; 33: 149-158
- Fifty percent area reduction after 4 weeks of treatment is a reliable indicator for healing---analysis of a single-center cohort of 704 diabetic patients.J Diabetes Complications. 2009; 23: 49-53
- A post-hoc analysis of reduction in diabetic foot ulcer size at 4 weeks as a predictor of healing by 12 weeks.Ostomy Wound Manage. 2010; 56: 44-50
- Risk factors for foot infections in individuals with diabetes.Diabetes Care. 2006; 29: 1288-1293
- Tissue-engineered skin substitutes.Expert Opin Biol Ther. 2002; 2: 25-34
- Human monocyte activation by biologic and biodegradable meshes in vitro.Surg Endosc. 2009; 24: 805-811
- In-vivo and in-vitro histological evaluation of two commercially available acellular dermal matrices.Hernia. 2011; 15: 147-156
- Design and analysis of pilot studies: Recommendations for good practice.J Eval Clin Pract. 2004; 10: 307-312
- A tutorial on pilot studies: The what, why and how.BMC Med Res Methodol. 2010; 10: 1
- An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database.BMC Med Res Methodol. 2013; 20: 104
- Development, validity, reliability, and responsiveness of a new leg ulcer measurement tool.Adv Skin Wound Care. 2004; 17: 187-196
- NIH Image. Online manual (version 1.61).https://imagej.nih.gov/nih-image/manual/contents.htmlDate accessed: March 1, 2021
- Technology assessment: Skin substitutes for treating chronic wounds.https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdfDate: 2012Date accessed: February 14, 2021
- Clinical safety data management definitions and standards for expedited reporting ICH topic E2A: Guidance for industry.https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/e2a-eng.pdfDate accessed: February 14, 2021
- The efficacy of Apligraf in the treatment of diabetic foot ulcers.Plast Reconstr Surg. 2006; 117 (152S–7S; discussion 158S–9S)
- Apligraf in the treatment of neuropathic diabetic foot ulcers.Int J Low Extrem. 2009; 8: 11-18
- The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers.Diabetes Care. 2003; 26: 1701
- Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: A prospective, randomised, multicentre study.Int Wound J. 2019; 6: 196-208
- A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers.Int Wound J. 2015; 12: 724-732
- Use of a new acellular dermal matrix for treatment of nonhealing wounds in the lower extremities of patients with diabetes.Wounds. 2013; 25: 340-344
- Healing rates in a multicenter assessment of a sterile, room temperature, acellular dermal matrix versus conventional care wound management and an active comparator in the treatment of full-thickness diabetic foot ulcers.Eplasty. 2016; 16: e10
- A multicenter study involving the use of a human acellular dermal regenerative tissue matrix for the treatment of diabetic lower extremity wounds.Adv Skin Wound Care. 2008; 21: 375-381
- A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator.Wound Repair Regen. 2017; 25: 483-497
- A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics.Int Wound J. 2019; 16: 19-29
Article Info
Publication History
Published online: April 06, 2022
Accepted:
March 29,
2022
Received in revised form:
February 9,
2022
Received:
July 15,
2021
Identification
Copyright
© 2022 Canadian Diabetes Association.
