A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The...
Venous UlcerVenous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.
Cell Therapy for Venous Leg Ulcers Pilot Study
Venous UlcerChronic venous leg ulcers (CVU) represent a medical problem associated with significant morbidity, increased work absenteeism and earlier retirement as a consequence of disability. This strongly affects the patient's quality of life and has a significant economic impact on healthcare systems. Reports of studies with animal models show that treatment with bone marrow-derived stem cells has a beneficial effect in healing chronic skin wounds. The purpose of this pilot study is to determine the safety and feasibility of cell therapy with bone marrow derived cells (BMDC) as a complementary healing therapy in chronic venous leg ulcers, and in addition to evaluate its effectiveness. The knowledge gained in the pilot study will be used to refine the clinical protocol procedures of a subsequent randomized study. Patients with venous legs ulcers meeting eligibility criteria and providing appropriate written informed consent will be enrolled for study participation. Enrolled patients will receive Autologous BMDC implantation at de venous ulcer in conjunction with standard of care (SOC) treatment. During follow up, adverse events will be assessed by ulcer clinical examination. Effectiveness of the experimental treatment will be assessed by evaluating ulcer healing (reduction of the ulcer area) and pain reduction over a six-month period.
Safety Evaluation of the KLOX BioPhotonic System in Venous Leg Ulcers
Venous Leg UlcersThe primary objective of these case series is to evaluate the safety and tolerability of the KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with venous leg ulcers.
Custom Foot Orthoses & Venous Status
FootFoot Orthoses2 moreThe purpose of the research is to compare the influence of customized foot orthoses use on the venous status among healthy female and male subjects. This is a quasi-experimental study which included 20 healthy subjects. Sociodemographic and medical record data are registered. Furthermore,venous function is evaluated by plethysmography, first, without orthoses and, after 20 days, with orthoses.
A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous...
Venous Leg UlcerVenous leg ulcers are lower extremity ulcers that develop due to sustained venous hypertension resulting from chronic venous insufficiency. Varicose veins, deep vein thrombosis, poor calf muscle function, arterio-venous fistulae, obesity and history of leg fracture are some of the risk factors for venous ulceration. Numerous dressing types exist to treat these ulcers. This study will compare a marine polysaccharide (MPS) dressing to a carboxymethylcellulose dressing to determine which dressing better manages these wounds with regard to wound size and periwound skin condition. Subjects will be randomized to receive either MPS-Ag dressing or CMC-Ag dressing.
Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers
Chronic Venous Hypertension With Ulcer and InflammationChronic Ulcer of Leg or FootChronic venous ulcers are considered a problem with a big morbidity impact on both the health facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers. In this study, the investigators compare combining autologous platelet rich plasma treatments with partial skin grafting in chronic ulcers, the results were compared to using only partial skin grafting, and among various types of chronic resistant ulcers.
Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately...
Venous Leg UlcerThe investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber®Gelling Fibre Dressing or Aquacel®Extra Hydrofiber® Dressing with Strengthening Fibre using, centralized randomization
Randomized Controlled 8-Week Crossover Evaluation of Compression Bandage Systems for Venous Leg...
Venous UlcerThe purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers.
DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency
Varicose VeinsVenous Stasis1 moreThis study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.
Evaluate the Impact of Drawtex in Venous Leg Ulcers
Moderatley to Highly Exuding Venous Leg UlcersThis is a clinical study to comparatively evaluate the impact of Drawtex wound dressing against wound bioburden in moderately to highly exuding venous leg ulcers.