View clinical trials related to Leg Ulcer.
Filter by:This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity ulceration and/or arterial insufficiency lower extremity ulceration.
The purpose of this study is to determine the clinical effectiveness of a low-power PEMF device, a medium-power PEMF device and a high-power PEMF device as compared to a sham device to treat leg ulcers resulting from venous stasis ("VSLU").
This is a single centre open label study measuring microcirculatory flux using Speckle imaging Device. Microcirculation will be measured using laser speckle contrast imaging, at baseline and with the device active for 30 minutes in the wound, peri-wound and other point on the lower leg. The same procedure will be done on all the different patient groups. Temperature variations can be assessed using Infrared Temperature Scanner (Exergen DermaTemp DT1001), a measurement will be taken at baseline, and then at 5 minutes interval during the 30 minutes activity of the device.
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.
The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers.
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.
This experimental study will look at the effects of INP therapy for two patient groups: 1) patients with reduced peripheral circulation and chronic wounds in patients with renal disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. The project is designed as a non-randomized clinical trial with single-subject multiple baseline design. Also the intervention will be subjected on the same leg for each individual throughout the study period. The other leg will act as a control. A baseline measure with patient history collection will be performed before a four-week intervention period. These measures include: Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and a health survey (SF-12/EQ-5D-5L) or similar. After four weeks and eight weeks of intervention, the same tests will be repeated. A final follow-up test will be two weeks after cessation of the intermittent negative pressure intervention. The study will look at the effect of INP on renal failure patients who are given dialysis at a dialysis center located at Oslo University Hospital, Ullevål. Otivio AS has supplied the FlowOx devices and provided the necessary training to perform this project. Outcome variables assessed before, during and after the 10-week study period will be: wound healing, quality of life, skin perfusion pressure and segmental pulse-volume recording. The aim of this project is to prospectively examine and elucidate the effect of intermittent negative pressure therapy on clinically relevant measures related to the reduction of peripheral macro- and microcirculation in patients with renal failure undergoing dialysis treatment. The hypothesis of the study is: - Application of INP in patients with renal failure, by the use of the FlowOx™ device, will improve wound healing and peripheral circulation in the foot compared to before treatment (baseline) in patients undergoing dialysis treatment. - Application of INP in patients with PAD, by the use of the FlowOx™ device, will improve macro- and microcirculation and wound healing in the foot compared to before treatment (baseline) in patients with chronic wounds.
To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of: - A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site, - Consumables necessary for the implementation of the dressing, - Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation. This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.
This efficacy study evaluates the safety and effectiveness of aspirin for venous leg ulcer healing. The study also examines whether patients can be recruited to a larger study. Patients with chronic venous leg ulceration presenting and undergoing care in leg ulcer community clinics or hospital out-patient clinics, or registered with a clinic but are receiving care at home will be recruited. All patients will receive standard compression bandaging. Half of the participants will be randomised to receive aspirin, while the other half will receive a placebo.