Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
Venous Ulcer of LegThis clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will result in a more accurate diagnosis of deep vein occlusion (DVO), will guide optimal therapy, and will provide better clinical outcomes with reduced cost of care for patients presenting with persistent venous leg ulcers (VLUs).
Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers
Venous Leg UlcerThis study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.
The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
Venous Leg UlcersThe purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, compression therapy alone for the treatment of venous leg ulcers.
Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients
Diabetic ComplicationsThis is a randomized controlled double blinded study involving two (2) investigational sites in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This is a 12-week study.
Pilot Study Comparing Negative Pressure Dressings to Conventional Dressings
Venous Leg UlcerThis study is being conducted to determine how the PICO™ Negative Pressure Wound Therapy compares to standard care treatment for venous stasis ulcers, as there is no evidence to date.
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy...
Venous Leg UlcersDiabetic Foot UlcersThe aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
Evaluation Of An Advanced Borderless Dressing
Pressure UlcerLeg Ulcer1 moreThis study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
VEGF Gene Transfer for Critical Limb Ischemia
Critical Limb IschemiaIschemia1 moreThe purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia (a condition in which there is poor blood circulation in the leg). This trial will assess whether VEGF improves rest pain and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg arteries.) VEGF is DNA, or genetic material that will be injected into the leg muscles on three separate occasions, each 2 weeks apart. Once the DNA is in the leg, it directs the cells of the artery wall to increase its production of VEGF, which has been shown to cause new blood vessels to grow. This experimental therapy is designed to grow new blood vessels around blockages in the leg arteries. The total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year. Following enrollment in the study, testing may be done for cancer screening, blood work, physical exams, vascular testing and eye exams. There is no charge for any testing or office visits required by the study. This study has been approved by the Food and Drug Administration (FDA).
A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device
Venous Leg UlcerThis is a single centre open label study measuring lower limb physiology in patients with venous leg ulcers at the University Hospital of South Manchester. Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in microcirculation will be measured at baseline after the gekoTM device is activated. Ambulatory venous pressure and venous transit times will be performed whilst the participant is standing, sitting and supine
Physical Activity Interventions for Leg Ulcer Patients
Leg UlcersVenous Ulcers1 moreThe 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.