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Foot Ulcer clinical trials

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NCT ID: NCT01108263 Terminated - Diabetes Clinical Trials

Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers

Start date: June 2010
Phase: Phase 4
Study type: Interventional

- After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group. - Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. This will be done before the INTEGRA application and at every other follow-up visit. - Both groups will be debrided and have pictures taken in the OR - Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected subcutaneously in the OR. - Subjects will be placed in a total contact cast at each visit. If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.

NCT ID: NCT01013792 Terminated - Clinical trials for Foot Ulcer, Diabetic

A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

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

The primary objective is to: - Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer. Secondary objectives are to: - Assess the adverse events that occur in subjects randomized to the investigational dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI technology. - Assess the costs of using the investigational dressing compared to the Tegaderm Matrix Dressing with PHI technology. - Assess and compare the impact that these dressings have on patients' quality of life. - Assess the wound's biological response and pH to the study dressings.

NCT ID: NCT00958711 Terminated - Clinical trials for Diabetic Foot Ulcers

The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

Start date: January 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, saline moistened gauze, for the treatment of diabetic foot ulcers.

NCT ID: NCT00820703 Terminated - Diabetic Foot Ulcer Clinical Trials

The ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon to Treat Slow Healing Diabetic Foot Ulcers

Start date: April 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is increased 8-fold in people with diabetes. New treatments that improve the number of ulcers that heal and/or speed up healing are urgently needed. Initial studies with a new drug called Nexagon® (developed by CoDa Therapeutics, Inc.) support the concept that healing of diabetic foot ulcers can be improved with topical application of Nexagon®. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to diabetic foot ulcers at various doses. A proposed randomized controlled trial will randomly allocate (e.g., by the toss of a coin) 24 people with diabetic foot ulcers to Nexagon® (one of three different doses) or vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed over four weeks to monitor their response to the treatment, specifically with regards to the amount of healing that occurs.

NCT ID: NCT00761176 Terminated - Clinical trials for Diabetic Foot Ulcers

A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers

Start date: July 2008
Phase: N/A
Study type: Interventional

The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic wound care alone.

NCT ID: NCT00731835 Terminated - Ischemic Foot Ulcer Clinical Trials

Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone

Start date: July 2008
Phase: N/A
Study type: Interventional

You are being asked to take part in this study because your doctor has determined that you have an ischemic foot ulcer. This research study will compare two approved standard of care treatment modalities for the management of ischemic foot ulcers. The ischemic foot ulcer (wound) on your foot is a result of a blocked artery in your leg. The wound can sometimes be healed with wound care alone, which includes dressing changes with creams and removing (debriding) the dead tissue. Alternatively, the significant narrowing or blockage in one of the arteries in your leg can be treated with several endovascular treatment techniques including: - angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or - stent placement - atherectomy The hypothesis of this study is that early endovascular or surgical intervention in subjects with moderate arterial insufficiency and a non-healing foot ulcer results in a higher overall incidence of wound healing in a significantly shorter period of time.

NCT ID: NCT00658957 Terminated - Diabetic Foot Ulcer Clinical Trials

Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer

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

The purpose of this study is to determine the safety and efficacy of the topical gentamicin collagen sponge (gentamicin sponge) combined with standard of care (daily wound care, off-loading, diabetic control and debridement by a physician or podiatrist), compared with placebo sponge combined with standard of care, in preventing infection of diabetic lower extremity skin ulcers.

NCT ID: NCT00605189 Terminated - Clinical trials for Diabetic Foot Ulcers

A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

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

A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.

NCT ID: NCT00434538 Terminated - Diabetic Foot Ulcer Clinical Trials

BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

Start date: February 2007
Phase: Phase 3
Study type: Interventional

This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers. The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers.

NCT ID: NCT00399425 Terminated - Clinical trials for Foot Ulcer, Diabetic

Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients

Start date: June 2001
Phase: Phase 2/Phase 3
Study type: Interventional

To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.