Active clinical trials for "Leg Ulcer"

To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding 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.

Epidermal grafts are believed to promote healing by two mechanisms: graft take and the promotion of wound healing through the delivery of growth factors and the essential elements of tissue repair and wound healing.28 This study is intended to establish the superior effectiveness of epidermal grafting and multi-layer compression over that of multi-layer compression alone, in the treatment of venous leg ulcers. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs). 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. Epidermal grafting has been a reconstructive option for decades; however, to date there has not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting System permits the harvesting of epidermal blister grafts at the patient's bedside without the need for anesthesia. The grafts can be easily transferred to the wound bed. In case studies, epidermal grafting appeared to be effective in reducing wound size and accelerating closure of venous leg ulcers.

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.

This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers

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.

Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers

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 reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.

The primary objective of the study is to demonstrate that the HM242-Gel performs at least comparably to INTRASITE Gel with regard to wound healing.