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. (September 2021)

• Record Type: Journal Article
• Authors: Çetinkalp, Şevki; Gökçe, Evren Homan; Şimşir, IlgınYıldırım; Tuncay Tanrıverdi, Sakine; Doğan, Fatma; Biray Avcı, Çığır; Eroğlu, İpek; Utku, Tülün; Gündüz, Cumhur; Özer, Özgen
• Is Part Of: International journal of lower extremity wounds. Volume 20:Number 3(2021)
• Page Start: 217
• Page End: 226
• Publication Date: 2021-09
• Subjects: diabetic foot wound -- collagen scaffold -- resveratrol -- laminin -- wound healing -- hyaluronic acid; Leg -- Wounds and injuries -- Periodicals; Wounds and injuries -- Prevention -- Periodicals; Leg -- Ulcers -- Periodicals; Wound healing -- Periodicals; 617.584
• DOI: 10.1177/1534734620907773
• Languages: English
• ISSNs: 1534-7346

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 in the first phase of wound would help the wound area heal faster with a safe profile.