View clinical trials related to Venous Leg Ulcer.
Filter by:Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.
This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey
The aim of this study is to determine the percentage of healing of active venous ulcers following Terminal Axial Perforator Interruption Reflux Source (tapirs technique) and adjustable compression system versus a control group using the traditional multilayer bandages.
Venous ulceration is a major burden on the NHS. Current treatment involves bandaging therapy which is replaced on a once or twice weekly basis. The Juxta-CuresTM device offers an alternative solution for the long-term treatment of patients with venous ulceration. This is a removable adjustable device with an inbuilt pressure monitor. The aim of this study is to determine whether the Juxta-Cures™ device provides at least equivalent ulcer healing for patients with venous ulceration compared to bandaging. Secondary outcome measures include whether the Juxta-Cures™ device improves patient compliance and quality of life compared to bandaging, and whether the Juxta-Cures™ device is cost effective compared to bandaging.
The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
The purpose of this study is to determine the systemic exposure of Granexin® gel after topical application to human subjects' venous leg ulcers.
The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill, population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled accelerometer and tracking device (BEAT) worn on the foot during a progressive and evidence-based non-exertive leg conditioning activities for lower leg function (CALF) captures minute foot movements and sends the data to a Smartphone. This six-week feasibility study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on functional outcomes in a very low fitness population.
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of cooling gel pack or placebo will be applied three times weekly to the affected skin, and a bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and quality of life will be measured.
Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain. Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Human amniotic membrane replaces the damaged extracellular matrix characteristic of chronic ulcers. In addition, it contains cytokines that may accelerate healing. In clinical practice and recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human Amniotic Membrane in venous leg ulcers.