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Leg Ulcer clinical trials

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NCT ID: NCT01801891 Completed - Clinical trials for Chronic Venous Disease

Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers

Start date: May 2013
Phase: Phase 2
Study type: Interventional

This study aims to determine if the use of surface neuromuscular electrical stimulation, applied to various motor points on the lower limb to elicit muscle contraction when combined with compression bandaging accelerates the rate of venous leg ulcer healing.

NCT ID: NCT01754506 Completed - Clinical trials for Venous Stasis Ulcers

Testing Fish Oil Derivatives In Healing Of Chronic Venous Leg Ulcers

Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (CVLU). If this systemic, nutrient intervention is found to alter the microenvironment of CVLU, the science of wound healing and care of patients with CVLU will be vastly improved.

NCT ID: NCT01750749 Completed - Venous Ulcer Clinical Trials

Cell Therapy for Venous Leg Ulcers Pilot Study

Start date: May 2011
Phase: Phase 1
Study type: Interventional

Chronic venous leg ulcers (CVU) represent a medical problem associated with significant morbidity, increased work absenteeism and earlier retirement as a consequence of disability. This strongly affects the patient's quality of life and has a significant economic impact on healthcare systems. Reports of studies with animal models show that treatment with bone marrow-derived stem cells has a beneficial effect in healing chronic skin wounds. The purpose of this pilot study is to determine the safety and feasibility of cell therapy with bone marrow derived cells (BMDC) as a complementary healing therapy in chronic venous leg ulcers, and in addition to evaluate its effectiveness. The knowledge gained in the pilot study will be used to refine the clinical protocol procedures of a subsequent randomized study. Patients with venous legs ulcers meeting eligibility criteria and providing appropriate written informed consent will be enrolled for study participation. Enrolled patients will receive Autologous BMDC implantation at de venous ulcer in conjunction with standard of care (SOC) treatment. During follow up, adverse events will be assessed by ulcer clinical examination. Effectiveness of the experimental treatment will be assessed by evaluating ulcer healing (reduction of the ulcer area) and pain reduction over a six-month period.

NCT ID: NCT01743053 Completed - Venous Leg Ulcers Clinical Trials

A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers

Start date: January 2013
Phase: Phase 4
Study type: Interventional

This is a prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for the management of chronic leg ulcers associated with venous insufficiency. Outcome will be compared between study participants receiving standard care (debridement, compression therapy) and participants receiving ReCell in addition to standard care.

NCT ID: NCT01673412 Completed - Leg Ulcer Clinical Trials

Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

Start date: January 2003
Phase: N/A
Study type: Interventional

This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU) characteristics known as possible prognostic markers, and which sociodemographic and psychologic factors associated with VLU are associated with complete healing at 24 weeks.

NCT ID: NCT01671748 Completed - Varicose Ulcer Clinical Trials

MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers

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

Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard treatment in the UK for patients with VLUs is compression bandaging or stockings. The MIST ultrasound system is a noncontact device which delivers low frequency ultrasound through a gentle saline mist directed at a patient's wound. This study aims to determine whether the use of the MIST device used in combination with standard treatments can improve healing of VLUs compared to UK standard practice. This will be assessed by measuring any reduction in wound size in the two groups after receiving 8 weeks of either Standard Care once a week or MIST combined with Standard Care three times a week.

NCT ID: NCT01656889 Completed - Venous Leg Ulcers Clinical Trials

Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

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

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

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: NCT01578382 Completed - Calciphylaxis Clinical Trials

Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)

Start date: September 2011
Phase:
Study type: Observational

Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction) which occurs in long-term hypertensive subjects. Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin infarction) which occurs in subjects with end-stage kidney disease or after kidney transplantation.

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.