Abstract: A 57-year-old African-American woman presented with a three-year-history of arthritis and changes in the quality of her skin. Over the past year, the skin on the medial aspect of the foot had ulcerated, and she was concerned about the large amount of drainage from the wound. She also complained of joint stiffness and pain, muscle cramps, and Raynaud’s phenomenon. Given the history of Raynaud’s syndrome and the presenting physical findings, the clinical diagnosis of linear scleroderma was felt to be most appropriate. In this article, the presentation, significant physical findings, etiology, and treatment plans for the patient are discussed.

Abstract: Bioengineered skin substitutes have emerged over the past 20 years as the most carefully studied and proven of the advanced wound management technologies. While the initial impetus for their development was to replace autograft, allograft, and xenograft in burn applications, they have found even wider application in the treatment of chronic venous and chronic diabetic ulcers. The current review addresses the history of skin substitutes, surveys the landscape of existing Food and Drug Administration-approved products and other promising innovations that appear close to market, and discusses the reasoning and controversies associated with design of these products. While acellular biologic constructs are discussed, the authors focus on products that include autologous or allogeneic cells. The various clinical trials supporting the use of skin substitutes for different wound healing indications are reviewed. The preponderance of literature supports the cost effectiveness of using

Abstract: Bioengineered skin substitutes have emerged over the past 20 years as the most carefully studied and proven of the advanced wound management technologies. While the initial impetus for their development was to replace autograft, allograft, and xenograft in burn applications, they have found even wider application in the treatment of chronic venous and chronic diabetic ulcers. The current review addresses the history of skin substitutes, surveys the landscape of existing Food and Drug Administration-approved products and other promising innovations that appear close to market, and discusses the reasoning and controversies associated with design of these products. While acellular biologic constructs are discussed, the authors focus on products that include autologous or allogeneic cells. The various clinical trials supporting the use of skin substitutes for different wound healing indications are reviewed. The preponderance of literature supports the cost effectiveness of using

Abstract: Recently developed wound care biomaterials derived from natural tissue sources have been shown to improve wound closure by stimulating granulation tissue deposition and epithelization of dermal wounds. These products may offer significant advantages to other available treatments for the management of venous ulcers. One such biomaterial, derived from porcine small intestinal submucosa (SIS), has shown promise as an effective treatment to manage full-thickness wounds. This is an interim analysis of a prospective, randomized, controlled, clinical trial currently being conducted to examine the effectiveness of SIS wound matrix in treating full-thickness venous leg ulcers. Patients meeting inclusion criteria were randomized to either receive treatment with the SIS wound matrix or a standard of care therapy. Ulcer size was determined at enrollment and weekly throughout treatment. Healing, as defined by full epithelization, was assessed at each visit for a period of up to 12 weeks.

Abstract: Normal cutaneous wound healing proceeds via an ordered cascade of events that is mediated by specific growth factors, growth factor receptors, and cytokines. In chronic wounds, such as those occurring in the lower extremities of individuals with diabetes, there is a significant deficiency of endogenous growth factors and growth factor receptors. Attempts to overcome these deficiencies through the use of growth factor protein therapeutics have yielded disappointing clinical outcomes. Growth factor gene therapy has therefore attracted attention as a therapeutic alternative to protein therapeutics. It is speculated that a gene therapy approach will prolong the availability of therapeutic proteins, yielding improved healing responses. This review summarizes the various vector systems, transgenes, and animal models that have been employed to assess the feasibility of growth factor gene therapy for cutaneous wound repair. The results have been very promising, warranting ongoing cli

Abstract: Multiple growth factor proteins have been evaluated as therapeutic agents for the treatment of chronic wounds. All have failed with the exception of one to produce clinically significant results. This is in part due to the labile nature of proteins, inadequate delivery methods, and poor retention within the wound. The authors have developed a matrix-immobilized gene therapy approach to overcome the limitations of protein therapy. This gene-activated matrix (GAM) approach consists of a biocompatible matrix that holds the gene therapy vector, increasing its availability to cells invading the wound site and serves as a scaffold to promote cellular in-growth. The wound healing activity of bovine Type I collagen formulated with a replication-incompetent adenoviral vector encoding platelet-derived growth factor-B is reviewed in three animal models. Increased granulation tissue formation and vascularization was seen in all three models compared to collagen alone-treated animals. The

Abstract: Designing clinical protocols as well as implementing and conducting clinical trials for advanced technology in wound care entails careful planning. Considerations and recommendations for appropriate trial design and site selection are briefly outlined this manuscript. The information presented is strictly the viewpoint of the editor and primarily is meant to stimulate thought when designing and implementing protocols for advanced clinical products and technologies. Selection of the study population, clinical sites, protocol design, investigators, and product applications are a few of the topics discussed.