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      Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open‐label, single‐arm feasibility study in diabetic foot ulcers

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          Abstract

          Diabetic foot ulcers (DFUs) are a growing burden on patients and health care systems that often require multiple treatments of both conventional and advanced modalities to achieve complete wound closure. A novel autologous homologous skin construct (AHSC) has been developed to treat cutaneous defects with a single topical application, by leveraging the endogenous repair capabilities of the patient's healthy skin. The AHSC's ability to close DFUs with a single treatment was evaluated in an open‐label, single‐arm feasibility study. Eleven patients with DFUs extending up to tendon, bone, or capsule received a single topical application of AHSC. Closure was documented weekly with high‐resolution digital photography and wound planimetry. All 11 DFUs demonstrated successful graft take. Ten DFUs closed within 8 weeks. The median time‐to‐complete closure was 25 days. The mean percent area reduction for all 11 wounds at 4 weeks was 83%. There were no adverse events related to the AHSC treatment site. This pilot study demonstrated AHSC may be a viable single application topical intervention for DFUs and warrants investigation in larger, controlled studies.

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          Most cited references 36

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          Lgr6 marks stem cells in the hair follicle that generate all cell lineages of the skin.

          Mammalian epidermis consists of three self-renewing compartments: the hair follicle, the sebaceous gland, and the interfollicular epidermis. We generated knock-in alleles of murine Lgr6, a close relative of the Lgr5 stem cell gene. Lgr6 was expressed in the earliest embryonic hair placodes. In adult hair follicles, Lgr6+ cells resided in a previously uncharacterized region directly above the follicle bulge. They expressed none of the known bulge stem cell markers. Prenatal Lgr6+ cells established the hair follicle, sebaceous gland, and interfollicular epidermis. Postnatally, Lgr6+ cells generated sebaceous gland and interfollicular epidermis, whereas contribution to hair lineages gradually diminished with age. Adult Lgr6+ cells executed long-term wound repair, including the formation of new hair follicles. We conclude that Lgr6 marks the most primitive epidermal stem cell.
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            A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers

            Our purpose was to compare healing characteristics of diabetic foot ulcers treated with dehydrated human amniotic membrane allografts (EpiFix®, MiMedx, Kennesaw, GA) versus standard of care. An IRB-approved, prospective, randomised, single-centre clinical trial was performed. Included were patients with a diabetic foot ulcer of at least 4-week duration without infection having adequate arterial perfusion. Patients were randomised to receive standard care alone or standard care with the addition of EpiFix. Wound size reduction and rates of complete healing after 4 and 6 weeks were evaluated. In the standard care group (n = 12) and the EpiFix group (n = 13) wounds reduced in size by a mean of 32·0% ± 47·3% versus 97·1% ± 7·0% (P < 0·001) after 4 weeks, whereas at 6 weeks wounds were reduced by −1·8% ± 70·3% versus 98·4% ± 5·8% (P < 0·001), standard care versus EpiFix, respectively. After 4 and 6 weeks of treatment the overall healing rate with application of EpiFix was shown to be 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds (P < 0·001), respectively. Patients treated with EpiFix achieved superior healing rates over standard treatment alone. These results show that using EpiFix in addition to standard care is efficacious for wound healing.
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              Biologic and synthetic skin substitutes: An overview

              The current trend of burn wound care has shifted to more holistic approach of improvement in the long-term form and function of the healed burn wounds and quality of life. This has demanded the emergence of various skin substitutes in the management of acute burn injury as well as post burn reconstructions. Skin substitutes have important roles in the treatment of deep dermal and full thickness wounds of various aetiologies. At present, there is no ideal substitute in the market. Skin substitutes can be divided into two main classes, namely, biological and synthetic substitutes. The biological skin substitutes have a more intact extracellular matrix structure, while the synthetic skin substitutes can be synthesised on demand and can be modulated for specific purposes. Each class has its advantages and disadvantages. The biological skin substitutes may allow the construction of a more natural new dermis and allow excellent re-epithelialisation characteristics due to the presence of a basement membrane. Synthetic skin substitutes demonstrate the advantages of increase control over scaffold composition. The ultimate goal is to achieve an ideal skin substitute that provides an effective and scar-free wound healing.
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                Author and article information

                Contributors
                cmzelen@periedu.com
                Journal
                Int Wound J
                Int Wound J
                10.1111/(ISSN)1742-481X
                IWJ
                International Wound Journal
                Blackwell Publishing Ltd (Oxford, UK )
                1742-4801
                1742-481X
                26 May 2020
                October 2020
                : 17
                : 5 ( doiID: 10.1111/iwj.v17.5 )
                : 1366-1375
                Affiliations
                [ 1 ] Keck School of Medicine University of Southern California California Los Angeles USA
                [ 2 ] Brigham and Women's Hospital Boston Massachusetts USA
                [ 3 ] Northwestern University School of Medicine Chicago Illinois USA
                [ 4 ] Drexel University Philadelphia Pennsylvania USA
                [ 5 ] Strategic Solutions, Inc. Cody Wyoming USA
                [ 6 ] The Professional Education and Research Institute (PERI) Roanoke Virginia USA
                [ 7 ] The Angiogenesis Foundation Cambridge Massachusetts USA
                Author notes
                [* ] Correspondence

                Charles M. Zelen, DPM, Professional Education and Research Institute, 222 Walnut Avenue, Roanoke, VA 24016.

                Email: cmzelen@ 123456periedu.com

                Article
                IWJ13404
                10.1111/iwj.13404
                7540349
                32453512
                © 2020 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                Page count
                Figures: 4, Tables: 4, Pages: 10, Words: 5748
                Product
                Funding
                Funded by: PolarityTE
                Award ID: Grant001
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                October 2020
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.9.2 mode:remove_FC converted:07.10.2020

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