Patients with chronic wounds should receive wound treatment in addition to causative therapy. In this context, the lack of adequate evidence for wound healing products has been repeatedly discussed. Using the example of TLC-sucrose octasulfate (TLC: technology lipido-colloid), the present review shows that there is significant data with good evidence and comparability in this area.
View Article and Find Full Text PDFObjective: Matrix metalloproteinases (MMPs) substantially contribute to the development of chronicity in wounds. Thus, MMP-inhibiting dressings may support healing. A systematic review was performed to determine the existing evidence base for the treatment of hard-to-heal wounds with these dressings.
View Article and Find Full Text PDFBackground: The pressure exerted by a compression device on a part of the body corresponds to the dosage of the compression therapy. Therefore, the pressure course under compression materials should be investigated in different clinical situations.
Material And Methods: Pressure measurements were carried out under different compression materials in lying, standing and walking positions within the framework of training, self-experimentation and in patients with venous leg ulcers.
J Vasc Surg Venous Lymphat Disord
November 2017
Objective: The objective of this study was to characterize factors associated with closure of venous leg ulcers (VLUs) in a pooled analysis of subjects from three randomized clinical trials.
Methods: Closure of VLUs after treatment with HP802-247, an allogeneic living cell therapy consisting of growth-arrested human keratinocytes and fibroblasts, vs standard therapy with compression bandaging was evaluated in three phase 3 clinical trials of similar design. Two trials enrolled subjects with VLUs ranging from 2 cm to 12 cm in area with 12-week treatment periods; the third trial enrolled subjects with VLUs between >12 cm and ≤36 cm with a 16-week treatment period.
In 2012 we reported promising results from a phase 2 clinical trial of HP802-247, a novel spray-applied investigational treatment for chronic venous leg ulcers consisting of human, allogeneic fibroblasts and keratinocytes. We now describe phase 3 clinical testing of HP802-247, its failure to detect efficacy, and subsequent investigation into the root causes of the failure. Two randomized, controlled trials enrolled a total of 673 adult outpatients at 96 centers in North America and Europe.
View Article and Find Full Text PDFJ Wound Ostomy Continence Nurs
February 2017
Purpose: To characterize and compare interface pressure profiles of an adaptive compression therapy (ACT) device and a traditional 4-layer bandage (4LB) system.
Design: A prospective, randomized, open-label, 1-arm, active controlled study.
Subjects: The sample comprised 12 healthy volunteers.
Importance: Anogenital warts are a common disorder associated with significant physical and mental distress and a substantial cause of health care costs.
Objective: To assess the efficacy of the topical application of nitric oxide delivered using acidified nitrite.
Design, Setting, And Participants: A multicenter, randomized, controlled, dose-ranging clinical trial was conducted in European genitourinary medicine clinics between December 20, 2001, and January 14, 2003.
Background: Chronic venous leg ulcers (CVU) are a common, unresolved medical problem. Silica gel fibre (SGF) is a novel biodegradable inorganic material developed to serve as a carrier substrate for the local release of pharmaceutical agents facilitating tissue repair.
Objectives: To assess the performance and safety of SGF in subjects with CVU.
A prospective, randomised, 12-week study was performed to evaluate the efficacy and tolerability of two compression methods for venous leg ulcers (VLUs); a new adaptive compression therapy (ACT) system, combining intermittent and sustained pneumatic compression (n = 38) and a conventional four-layer bandage system (n = 52). Primary outcomes were ulcer healing and safety. Secondary outcomes were comfort, compliance, ulcer pain, patient-perceived product performance and quality of life.
View Article and Find Full Text PDFThe aim of this study was to evaluate the cytotoxic effect of octenidine dihydrochloride/phenoxyethanol (OHP) found in vitro by conducting a randomized, double-blind controlled clinical study focusing on its safe and effective use in chronic venous leg ulcers. In total, 126 male and female patients were treated with either OHP (n = 60) or Ringer solution (n = 66). The treatment lasted over a period of maximum 12 weeks.
View Article and Find Full Text PDFBackground: Two phase II clinical studies used an experimental, multi-chambered compression device with different cuff pressure combinations in subjects with leg edema and chronic venous insufficiency. The objective of each study was to evaluate the safety and the relative effects of different cuff pressure combinations to determine if edema reduction was dose-dependent.
Methods: Each study enrolled adults with chronic (>or=6 weeks) venous edema corresponding to CEAP C(3)-C(5).
Background: Treatment of depigmented skin is an unmet medical need.
Objective: Melanocytes or stem cells thereof residing in the outer root sheath (ORS) of hair follicles might be used to repigment skin.
Methods: After de-epidermisation, autologous ORS cell solutions were applied to 5 patients with vitiligo and 1 with leucoderma.
Venous leg ulcers are the most prevalent form of chronic wounds in the Western world. The principles of moist wound healing coupled with the use of graduated compression bandaging have become the cornerstone of treatment for venous leg ulcers but not all moist dressings are alike. To compare the attributes of a foam composite dressing with those of a hydrocellular foam dressing in the management of venous leg ulcers, a prospective, randomized, comparative 12-week study was conducted in 15 centers in the US, Canada, France, Germany, and the UK.
View Article and Find Full Text PDFThe healing process in acute wounds has been extensively studied and the knowledge derived from these studies has often been extrapolated to the care of chronic wounds, on the assumption that nonhealing chronic wounds were simply aberrations of the normal tissue repair process. However, this approach is less than satisfactory, as the chronic wound healing process differs in many important respects from that seen in acute wounds. In chronic wounds, the orderly sequence of events seen in acute wounds becomes disrupted or "stuck" at one or more of the different stages of wound healing.
View Article and Find Full Text PDFAcademic, clinical and industrial efforts are increasingly being directed toward the use of molecular- and cell-based therapies for diagnosis and treatment of a great number and broad variety of pathologies and injuries. Hence, tissue engineering is, next to genetic engineering, widely heralded as the healthcare technology heir of the revolutionary advances in life sciences. In a cost-controlled healthcare environment, only those technologies capable of providing a major enhancement to quality of life and a reduction in expenditure will be driven forward.
View Article and Find Full Text PDFExtracts from Butcher's broom rhizome (Ruscus aculeatus) have been widely used in the oral treatment of lower leg edema in patients with chronic venous insufficiency. The aim of the present multi-center, double-blind, randomized, placebo-controlled trial was to confirm the efficacy and safety of a ruscus extract (Fagorutin Ruscus Kapseln) according to the latest scientific standards. 166 women suffering from chronic venous insufficiency (Widmer grade I and II, CEAP (Clinical signs, Etiological classification, Anatomic distribution, Pathophysiology) 3-4) were included.
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