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Varicose Ulcer clinical trials

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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: 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: NCT00832091 Completed - Clinical trials for Venous Stasis Ulcers

Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

SSVS
Start date: July 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

NCT ID: NCT00823446 Completed - Clinical trials for Venous Stasis Ulcers

Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers

Start date: March 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.

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: NCT00815217 Not yet recruiting - Diabetic Wounds Clinical Trials

The Role of Lipoaspirate Injection in the Treatment of Diabetic Lower Extremity Wounds and Venous Stasis Ulcers

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

A prospective, single blinded randomized clinical study will be performed to determine if the injection of lipoaspirate into diabetic or venous stasis wounds promotes wound healing or wound closure at a faster rate than conventional treatment.

NCT ID: NCT00797706 Active, not recruiting - Clinical trials for Chronic Venous Leg Ulcers

Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers

Start date: November 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when administered to individuals suffering from venous leg ulcers.

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: NCT00727701 Terminated - Varicose Ulcer Clinical Trials

Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

Start date: July 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether individualized wound prevention instructions will lengthen the ulcer-free period in veterans with recently healed venous ulcers.

NCT ID: NCT00720239 Completed - Clinical trials for Venous Insufficiency

Taliderm Dressing for Venous Ulcers

Start date: February 2008
Phase: Phase 0
Study type: Interventional

The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that causes ulcers to develop on the lower legs. This new dressing is hoped to help the ulcers heal more quickly. The study hypothesis is to determine whether the TalidermR Wound Dressing, a poly-N-acetyl glucosamine (pGlcNAc) derived membrane material expedites wound healing in humans with venous stasis ulcers.