Comparative Evaluation of Clinical Efficacy and Safety of Collagen Laminin-Based Dermal Matrix Combined With Resveratrol Microparticles (Dermalix) and Standard Wound Care for Diabetic Foot Ulcers.

The International Journal of Lower Extremity Wounds
Şevki ÇetinkalpÖzgen Özer

Abstract

This is an open, prospective, comparative parallel-arm medical device clinical study of Dermalix (Dx) in diabetic foot wounds. Dx is a 3-dimensional collagen-laminin porous-structured dermal matrix prepared and additionally impregnated with resveratrol-loaded hyaluronic acid and dipalmitoylphosphatidylcholine-based microparticles. The aim was to evaluate the efficacy and safety of Dx, an investigational medical device, in Wagner 1 and 2 wounds in comparison to a standard wound care (SWC) that consists of irrigation and cleaning with sterile saline solution. Forty-eight patients were randomized to receive either SWC or SWC + Dx. A 4-week treatment period was followed by a 2-month follow-up without treatment. The wound area measurement, total collagen, vascular epidermal growth factor, tumor necrosis factor, interleukin 1, caspase 3, glutathione, reduced/oxidized glutathione, and lipid peroxidation levels were evaluated. At the end of 4 weeks, the percentage closures of wounds were determined as 57.82% for Dx, and 26.63% for SWC groups. Dx had a significant effect on tumor necrosis factor, caspase 3, and reduced/oxidized glutathione levels. Dx provided 2 times faster wound healing and decreased oxidative stress. Application of Dx...Continue Reading

References

Nov 19, 2003·Advanced Drug Delivery Reviews·Zbigniew Ruszczak
Oct 10, 2008·The New England Journal of Medicine·John Chalmers, Mark E Cooper
Jul 8, 2010·Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology·S P ZhongC T Lim
Oct 30, 2010·Circulation Research·Ferdinando Giacco, Michael Brownlee
Jan 11, 2011·Archives of Biochemistry and Biophysics·Mary NdiayeNihal Ahmad
Feb 23, 2011·International Journal of Molecular Sciences·Ralee Spooner, Ozlem Yilmaz
Jun 22, 2011·Medical Hypotheses·Yuriy K BashmakovIvan M Petyaev
Jul 1, 2010·Pharmacognosy Reviews·V LoboN Chandra
Apr 25, 2012·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Kleopatra Alexiadou, John Doupis
May 16, 2013·Tissue Engineering. Part B, Reviews·Qiu Li Loh, Cleo Choong
Sep 3, 2013·Antioxidants & Redox Signaling·Manish MittalAsrar B Malik
Jul 6, 2014·Physiological Reviews·Dmitry B ZorovSteven J Sollott
Oct 11, 2014·Advances in Wound Care·Kelly E Johnson, Traci A Wilgus
Dec 17, 2014·World Journal of Diabetes·Awadhesh K AryaKamlakar Tripathi
Feb 17, 2015·World Journal of Diabetes·Leila YazdanpanahSara Adarvishi
Aug 25, 2015·Wound Repair and Regeneration : Official Publication of the Wound Healing Society [and] the European Tissue Repair Society·Vickie R DriverKevin C Chung
Sep 5, 2015·Advances in Wound Care·Robert G Frykberg, Jaminelli Banks
Dec 1, 2015·World Journal of Experimental Medicine·Valter Lubrano, Silvana Balzan
May 18, 2016·Cellular and Molecular Life Sciences : CMLS·Ning Xu LandénMona Ståhle
May 4, 2017·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Evren H GokceOzgen Ozer
May 15, 2018·Frontiers in Bioengineering and Biotechnology·Matthew S BrownAhyeon Koh
Jul 10, 2018·Advances in Wound Care·Jacqueline LaroucheMikaël M Martino

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Citations

May 6, 2021·International Wound Journal·Andrzej HeckerPetra Kotzbeck
May 6, 2021·The International Journal of Lower Extremity Wounds·Geice P de SousaVinicius S Cardoso
Jun 27, 2021·Advanced Healthcare Materials·Mojtaba Farahani, Abbas Shafiee
Aug 6, 2021·The International Journal of Lower Extremity Wounds·Nikolaos PapanasKittipan Rerkasem

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Methods Mentioned

BETA
amputations
amputation
biopsy
pregnancy test

Clinical Trials Mentioned

NCT03136822

Software Mentioned

PASW SPSS )

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