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Diabetic Foot clinical trials

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NCT ID: NCT01098357 Completed - Clinical trials for Diabetic Foot Ulcers

Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer

Start date: June 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, active-control, multicentre, parallel group, randomised and dose-finding efficacy and safety study. Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the treatment of neuropathic diabetic foot ulcer. Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days for up to 20 weeks.

NCT ID: NCT01082445 Completed - Clinical trials for Foot Ulcer, Diabetic

Effects of N-acetylcysteine on Diabetic Foot Oxygenation

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether N-acetylcysteine is effective in the treatment or prevention of the foot ulcers in diabetic patients.

NCT ID: NCT01070433 Completed - Clinical trials for Diabetic Foot Ulcers

A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers

Start date: September 2012
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

NCT ID: NCT01068171 Withdrawn - Clinical trials for Diabetic Foot Ulcers

Developing a Diabetic Foot Ulcer Protocol

Start date: May 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way.

NCT ID: NCT01065337 Completed - Diabetic Foot Clinical Trials

Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia

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

Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent [BOLD]). Patients also underwent imaging with angiographic methods.

NCT ID: NCT01060670 Completed - Clinical trials for Foot Ulcer, Diabetic

A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers

Start date: April 2010
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, and without significantly compromised arterial circulation.

NCT ID: NCT01056198 Completed - Clinical trials for Diabetic Foot Ulcers

Santyl vs. Sharp Debridement of Diabetic Foot Wounds

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

This study tests two different approaches to the removal of dead tissue from the surface of a wound.

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: NCT01005264 Completed - Diabetic Foot Clinical Trials

Removable Walker for Neuropathic Ulcers

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

1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer 2. Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.

NCT ID: NCT00999635 Completed - Diabetes Clinical Trials

A Comparison of Insoles Used to Prevent Neuropathic Diabetic Foot Ulceration

Start date: March 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Importance of the topic: Lower extremity amputation is a costly complication of diabetes for both the NHS and the patient. Amputation may be avoided if the preceding foot ulceration can be prevented. One method of reducing the risk of ulceration in the neuropathic foot is through the provision of therapeutic insoles. The type of insole prescribed (prefabricated verses custom made) is currently based on anecdotal evidence. The idea held by many practitioners that the custom made insole is superior in its effect remains speculation, unsupported by the evidence. In the absence of economic analysis, the available data suggests that the custom insole is substantially more expensive to the NHS. This study, to determine which of two types of insole used in therapeutic shoes reduces peak pressure more in the at−risk diabetic foot, is therefore a very important topic and will provide both useful evidence for the NHS podiatry services. It is of course also very important for patients with diabetes as the personal suffering of those undergoing amputation is immense. The study is a single blind randomised controlled trial comparing custom made with 'off the shelf' insoles.