[Sucrose octasulfate-evidence in the treatment of chronic wounds].

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.

Efficacy of MMP-inhibiting wound dressings in the treatment of chronic wounds: a systematic review.

Objective: 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.

[Importance of adequate pressure in compression therapy : Basis for successful treatment].

Background: 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.

Baseline factors affecting closure of venous leg ulcers.

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.

[Compression therapy of venous leg ulcers in the decongestion phase].

Compression therapy is the basis for successful treatment in most patients with venous leg ulcers. Concerning compression therapy, the initial phase of decongestion and the following phase of maintenance should be differentiated. While in the maintenance phase (ulcer) stocking systems are now frequently recommended, in the decongestion phase compression bandages are mostly still used, which however are often inappropriately applied.

Phase 3 evaluation of HP802-247 in the treatment of chronic venous leg ulcers.

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.

Comparison of 4-Layer Bandages and an Adaptive Compression Therapy Device on Intended Pressure Delivery.

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.

Evaluation of the Efficacy, Safety, and Tolerability of 3 Dose Regimens of Topical Sodium Nitrite With Citric Acid in Patients With Anogenital Warts: A Randomized Clinical Trial.

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.

Randomized standard-of-care-controlled trial of a silica gel fibre matrix in the treatment of chronic venous leg ulcers.

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.

Adaptive compression therapy for venous leg ulcers: a clinically effective, patient-centred approach.

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.

Evaluation of two fibrous wound dressings for the management of leg ulcers: results of a European randomised controlled trial (EARTH RCT).

Objective: To evaluate the performance (efficacy, safety and acceptability) of a new micro-adherent absorbent dressing (UrgoClean®) compared with a hydrofiber dressing (Aquacel®) in the local management of venous leg ulcers, in the debridement stage.

Method: A non-inferiority European randomised controlled clinical trial (RCT) was conducted in 37 centres, on patients presenting with venous or predominantly venous, mixed aetiology leg ulcers at their sloughy stage (with more than 70% of the wound bed covered with slough at baseline). Patients were followed over a 6-week period and assessed weekly.

Effectiveness and tissue compatibility of a 12-week treatment of chronic venous leg ulcers with an octenidine based antiseptic--a randomized, double-blind controlled study.

The 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.

Dose-response of compression therapy for chronic venous edema--higher pressures are associated with greater volume reduction: two randomized clinical studies.

Background: 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).

Repigmentation by outer-root-sheath-derived melanocytes: proof of concept in vitiligo and leucoderma.

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.

A prospective study on the use of a non-adhesive gelling foam dressing on exuding leg ulcers.

Objective: This non-comparative phase II study aimed to evaluate the safety and performance of a non-adhesive gelling foam dressing (GFD-N) in leg ulcer management.

Method: Forty-six subjects with moderately to heavily exuding leg ulcers were treated with a regimen including GFD-N. Dressings were changed at least every seven days for four weeks or until healing.

Treatment of recalcitrant venous leg ulcers with autologous keratinocytes in fibrin sealant: a multinational randomized controlled clinical trial.

In a multicenter trial, the effect of a commercially available combination of autologous keratinocytes (3-6 x 10(6)/mL) with fibrin sealant (Tissucol Duo S Immuno, Baxter Hyland Immuno) on the healing of recalcitrant venous leg ulcers (duration >3 months) was compared with standard care. The primary endpoint was time to healing, and the secondary endpoint was number of healed ulcers in both groups. Both groups received compression therapy with short-stretch bandages.

[Systematic management of chronic wounds employing the TIME concept].

The notion that chronic wounds are merely a variant of acute wounds is obsolete. The pathophysiology of chronic wounds differs in essence from that of acute wounds. The former is a specific pathological entity that requires both a systematic disease-specific diagnostic work-up and treatment.

Enzymatic versus autolytic debridement of chronic leg ulcers: a prospective randomised trial.

Objective: A randomised clinical trial (n = 42) compared the effectiveness of two approaches to debriding chronic leg ulcers: TenderWet 24, which is designed to support the autolytic degradation process, and Iruxol N (Santyl), an enzymatic treatment claimed to enhance the degradation process.

Method: Patients were randomly assigned to one of the two treatment groups for three weeks. Wounds were evaluated weekly for the amount of eschar/slough, the area of healthy granulation and the re-epithelialised area.

Development, validation and clinical use of the FLQA-I, a disease-specific quality of life questionnaire for patients with lymphedema.

Background: It is known from clinical practice that lymphatic diseases can be associated with reductions of quality of life (QoL). Due to the lack of validated methods, only few studies however have systematically investigated the QoL in lymphedema. The aim of the study was 1) to develop a standardized QoL questionnaire specific for lymphedema and 2) to assess the QoL in these patients.

Treatment of therapy-refractive ulcera cruris of various origins with autologous keratinocytes in fibrin sealant.

Background: Evaluation of the effects of cultivated, subconfluent, autologous keratinocytes in fibrin sealant (BioSeed-S) on the healing of therapy-refractive chronic wounds.

Patients And Methods: Open observational study in 60 patients with chronic leg ulcers and impaired wound healing of various origins. After whole-skin excision and cultivation of the autologous keratinocytes, the suspended cells were applied to the preconditioned wound in fibrin sealant.

Comparing a foam composite to a hydrocellular foam dressing in the management of venous leg ulcers: a controlled clinical study.

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.