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Varicose Ulcer clinical trials

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NCT ID: NCT01594658 Completed - Venous Ulcer Clinical Trials

Venous Ulcer Treatment With Foam Versus Conservative Treatment

VUTEF
Start date: July 2011
Phase: N/A
Study type: Observational

The venous ulcer due to venous insufficiency causes an important morbility to those people suffering from this condition. Most of therapies available under the obligatory health plan (POS, acronym in spanish) to date cover the cleaning of the ulcerous lesion and its medical handling using saline solutions, topical antibiotics and elastic dressings, implying an important intake from health resources due to its chronicity and the delay in ulcers healing, which usually takes periods ranging from 6 months to several years. therapeutical alternatives, which can guarantee optimal, fast and persistent in time healings, should be identified. The aim of this study is to determine the percentage of healing of active venous ulcers (using a clinical, etiological, anatomic and physiopathologic classification (CEAP), C6) following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration after six months from the intervention, compared with conservative medical handling. The investigators expect that the ultrasound-guided foam sclerotherapy of superficial venous reflux will diminish the time of ulcer healing compared with standard handling.

NCT ID: NCT01591434 Completed - Leg Ulcer Clinical Trials

Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Start date: May 2012
Phase: Phase 3
Study type: Interventional

Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.

NCT ID: NCT01567150 Completed - Clinical trials for Venous Stasis Ulcers

Wound Fluid Protease Levels During Use of Novel Wound Dressing

Start date: February 2012
Phase: Phase 4
Study type: Interventional

This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.

NCT ID: NCT01552447 Completed - Venous Leg Ulcer Clinical Trials

Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers

Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of venous leg ulcers.

NCT ID: NCT01549860 Completed - Clinical trials for Venous Insufficiency

Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers

Start date: April 2012
Phase: N/A
Study type: Interventional

This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care (SOC) alone in the treatment of lower extremity venous ulcers.

NCT ID: NCT01509599 Completed - Clinical trials for Venous Insufficiency

Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation

Start date: August 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Leg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, boot-like gel wrap placed around the damaged skin of the lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression stockings) intervention compared to a low compression non-cryotherapy "sham" wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5 venous insufficiency.

NCT ID: NCT01497210 Completed - Leg Ulcer Clinical Trials

EASH Dressing on Chronic Venous Leg Ulcers

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.

NCT ID: NCT01449422 Completed - Varicose Ulcer Clinical Trials

Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers.

Start date: May 2011
Phase: Phase 4
Study type: Interventional

The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.

NCT ID: NCT01372020 Completed - Clinical trials for Chronic Venous Insufficiency

Neuromuscular Electrical Therapy in Venous Ulcers

Start date: February 2011
Phase: Phase 4
Study type: Interventional

The use of neuromuscular electrical stimulation in the treatment of venous ulcers with difficulty of repair could be an alternative therapeutic favoring devitalized tissues and hence the pain. The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency.

NCT ID: NCT01348581 Completed - Pressure Ulcers Clinical Trials

Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing

Start date: November 2010
Phase: N/A
Study type: Interventional

The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds. The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology. The indications for use are: - partial and full-thickness wounds - pressure ulcers - venous ulcers - diabetic ulcers - chronic vascular ulcers - tunneled/undermined wounds - trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)