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Skin Ulcer clinical trials

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NCT ID: NCT01219127 Active, not recruiting - Skin Ulcer Clinical Trials

The Regeneration Effects of Derma-PACE Shockwave in Chronic Diabetic Ulcers

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

Management of chronic diabetic foot skin ulcers require multidisciplinary approaches including diabetic control, wound care, antibiotic, shoe wear off-loading, and surgery in selected cases. The results are inconsistent and irregular, and most studies reported unsatisfactory results. Many adjunctive therapies are implemented in the care of chronic diabetic foot ulcers including hyperbaric oxygen therapy (HBO), ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB), vacuum assisted wound closure (VAWC) and acellular matrix. HBO is the most commonly utilized at the investigators institution. Mixed results of HBO in chronic diabetic foot ulcers are reported. Several studies reported that the beneficial effects of HBO, but none showed universal success. Therefore, the development of a new effective method of treatment for chronic diabetic ulcers is extremely valuable. Extracorporeal shockwave therapy (ESWT) acts as mechanotransduction that produces the therapeutic benefits through complex biological pathways including neovascularization and tissue regeneration. ESWT also showed bacteriostatic effects in experiments. Some studies reported the effectiveness of ESWT in acute and chronic soft tissue wounds. Others reported effectiveness of ESWT in chronic ulcers with 50% completely healed with 6 sessions of treatment. With this background, it appears that ESWT may be effective in the treatment of chronic diabetic foot ulcers. The purpose of this study is to evaluate the efficacy of ESWT in chronic foot ulcers, and to compared with that treated with HBO, and to study the molecular and blood flow perfusion before and after ESWT.

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.

NCT ID: NCT00790608 Terminated - Clinical trials for Methicillin-resistant Staphylococcus Aureus Infection

Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)

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

The purpose of the study is to determine if topically applied nitric oxide gas is effective in reducing the quantity of bacteria (including MRSA)in a wound.

NCT ID: NCT00701974 Suspended - Ulcers Clinical Trials

Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers

Start date: February 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are from other causes. Clinical studies show that collagenase is an effective drug and presents high tolerabildade in the treatment of ulcerative burns and injuries of various etiologies. Evidence show statistically significant reduction of inflammation, the formation of granulation tissue, decrease in injuries and reepitelization.

NCT ID: NCT00691821 Terminated - Pressure Ulcer Clinical Trials

Negative Pressure Wound Therapy for the Treatment of Chronic Pressure Wounds

NPWT
Start date: April 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the difference in the percent reduction in wound surface area, without surgery, of chronic pressure ulcers of the pelvic region for Negative Pressure Wound Therapy (NPWT) compared to the standard dressing. This study is designed to provide evidence regarding NPWT as compared to standard dressing regimens and compare the efficacy, safety, effectiveness and cost-effectiveness.

NCT ID: NCT00624273 Completed - Clinical trials for Active Digital Ulcers

Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis

Sildenafil
Start date: February 2004
Phase: Phase 2
Study type: Interventional

This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and analyze the effect of sildenafil on angiography.

NCT ID: NCT00319696 Completed - Digital Ulcers Clinical Trials

Bosentan in Digital Ulcers

RAPIDS 2 OL
Start date: July 8, 2004
Phase: Phase 3
Study type: Interventional

The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

NCT ID: NCT00207818 Completed - Venous Ulcers Clinical Trials

Treatment of Cutaneous Ulcers With a Novel Biological Dressing

Start date: September 1999
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.

NCT ID: NCT00077584 Completed - Systemic Sclerosis Clinical Trials

Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

RAPIDS-2
Start date: October 2003
Phase: Phase 3
Study type: Interventional

In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.