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Venous Leg Ulcer clinical trials

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NCT ID: NCT00933348 Suspended - Pressure Ulcer Clinical Trials

Safety and Efficacy of the Fruit-based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers

Start date: January 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the safety and efficacy of the fruit-based product OPAL A for the treatment of chronic venous and pressure 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: NCT00847002 Terminated - Venous Ulcer Clinical Trials

Flexitouch Treatment for Venous Ulcers

Start date: September 2007
Phase: N/A
Study type: Interventional

This is a study to compare the healing process of venous stasis ulcers when the Flexitouch® system is added to the standard treatment of venous ulcers. We hypothesize that adding the Flexitouch® system to standard venous ulcer treatment will result in 1. greater complete healing 2. greater percentage reduction in ulcer area 3. reduced time to complete healing, as compared to the use of standard treatment alone 4. a greater reduction in affected leg volume as compared to standard treatment alone.

NCT ID: NCT00820196 Completed - Venous Ulcer Clinical Trials

A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)

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

Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.

NCT ID: NCT00759434 Completed - Varicose Veins Clinical Trials

A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value

Start date: March 2004
Phase: N/A
Study type: Interventional

Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL). Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury. Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years. 26% of NHS patients were 'very dissatisfied' with their varicose vein surgery. Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins. Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out. The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.

NCT ID: NCT00663091 Completed - Venous Leg Ulcers Clinical Trials

A Prospective, Randomized, Double-Blind Controlled Study of WPP-201 for the Safety and Efficacy of Treatment of Venous Leg Ulcers

WPP-201
Start date: September 2006
Phase: Phase 1
Study type: Interventional

To test safety and efficacy of Bacteriophage on Venous Leg Ulcers.

NCT ID: NCT00613808 Terminated - Venous Ulcers Clinical Trials

Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers

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

The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.

NCT ID: NCT00558662 Completed - Venous Ulcer Clinical Trials

Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers

Start date: November 2007
Phase: N/A
Study type: Interventional

The study purpose is to compare healing rates, cost effectiveness, quality of life and safety of 12 week compression therapy for the treatment of venous leg ulcers with the 3M™ Coban™ 2 Layer Compression System versus short-stretch compression bandage.