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Leg Ulcer clinical trials

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NCT ID: NCT01036438 Completed - Venous Leg Ulcers Clinical Trials

Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

Start date: December 2009
Phase: Phase 4
Study type: Interventional

Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.

NCT ID: NCT00998673 Terminated - Venous Ulcer Clinical Trials

Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

Start date: April 2009
Phase: Phase 2
Study type: Interventional

Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and will be hold in place by a secondary dressing for maintaining the moist wound environment. The study is aimed to demonstrate superiority over a standard wound treatment for chronic venous leg ulcers. The primary efficacy variable is time to healing.

NCT ID: NCT00970697 Completed - Clinical trials for Hypertensive Leg Ulcer

Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers

ERAN
Start date: January 2004
Phase: Phase 3
Study type: Interventional

Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial. Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel. Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed. Primary aim of the study: Complete closure at week 8 Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed

NCT ID: NCT00953563 Withdrawn - Venous Leg Ulcers Clinical Trials

The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

Start date: March 2009
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT00909870 Completed - Venous Leg Ulcer Clinical Trials

Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

DEVO
Start date: June 2009
Phase: Phase 3
Study type: Interventional

This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.

NCT ID: NCT00900029 Completed - Venous Leg Ulcer Clinical Trials

Safety Follow-Up to HP 802-247-09-015

Start date: June 2009
Phase: N/A
Study type: Observational

The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.

NCT ID: NCT00852995 Completed - Venous Leg Ulcer Clinical Trials

Dose Finding Study of HP802-247 in Venous Leg Ulcers

Start date: February 2009
Phase: Phase 2
Study type: Interventional

This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.

NCT ID: NCT00838500 Completed - Clinical trials for Venous Insufficiency

THERMES ET VEINES: Spa for Prevention of Leg Ulcers

Start date: May 2008
Phase: Phase 3
Study type: Interventional

The main objective of this study is to test the hypothesis that a 3 week intensive course of spa therapy can reduce the risk of leg ulcers in patients with advanced chronic venous insufficiency (C4a-b and C5 of the CEAP classification) at one year.

NCT ID: NCT00825760 Completed - Wound Healing Clinical Trials

Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Some leg ulcers do not seem to respond that well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing. Because we need to be careful about when we use antibiotics, this study will look at another way of killing bacteria in the ulcer. This new method involves putting a special gel on the ulcer and then shining a particular type of light (visible red light) onto the ulcer for a short period of time. In the first part of the study, a single treatment with the gel and light will be investigated. The second part of the study will compare whether or not using the treatment once a week for 12 weeks is better than placebo. Across the UK 57 people with chronic leg ulcers will be asked to take part in this study (9 in part 1 and 48 in part 2). Up to 10 sites will be involved including Cardiff University and hospitals in Bradford, Harrogate, Dundee, Hull, Plymouth and the Wirral. The research is funded by Photopharmica Ltd.

NCT ID: NCT00823095 Terminated - Clinical trials for Chronic Ulcer of Lower Extremity

Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

Start date: December 2005
Phase: Phase 2
Study type: Interventional

To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.