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Diabetic Foot clinical trials

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NCT ID: NCT01594762 Completed - Clinical trials for Diabetic Foot Infection

Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

OneStep-2
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.

NCT ID: NCT01590758 Completed - Clinical trials for Diabetic Foot Infection

Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

OneStep-1
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.

NCT ID: NCT01580917 Completed - Clinical trials for Foot Ulcer, Diabetic

Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study

ILH
Start date: November 2007
Phase: N/A
Study type: Observational

The purpose of this pilot study is to compare the dynamic response of microcirculation in the skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better understand the role of local hypoxia in neuropathic foot ulceration in subjects with diabetes. The investigators hypothesize that if they apply a gait simulating load to the plantar foot and measure microvascular function, diabetic individuals will demonstrate an increased delay in reestablishing microvascular flow compared to healthy individuals.

NCT ID: NCT01552499 Completed - Diabetic Foot Ulcer Clinical Trials

Comparative Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers.

NCT ID: NCT01551667 Completed - Infection Clinical Trials

Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds

ORISA
Start date: November 2012
Phase: N/A
Study type: Observational

The primary objective of this study is to detect differences in anti-S. aureus antibody assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia due to a chronic wound (cases) and (2) a group of patients with localized chronic wound infections (control).

NCT ID: NCT01490879 Completed - Clinical trials for Diabetic Foot Ulcers

A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)

DUNE
Start date: July 2012
Phase: Phase 2
Study type: Interventional

This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care. Standard of care will include debridement of the ulcer, standardized dressings and standardized off-loading using a Removable Cast Walker.

NCT ID: NCT01480362 Completed - Clinical trials for Foot Ulcer, Diabetic

Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds

DiaFu
Start date: November 2011
Phase: N/A
Study type: Interventional

On behalf of a consortium of 19 health insurance companies the Institute for Research in Operative Medicine as part of the University of Witten / Herdecke gGmbH is planning and conducting a clinical study evaluating the efficacy and effectiveness of negative pressure wound therapy in the treatment of wound healing disorders of the foot, which are caused by diabetes mellitus. This german multicenter study is due to evaluate whether the negative pressure wound therapy or the control therapy (standard wound therapy following the guidelines) is superior. Patients will be randomly assigned to the two study arms. Both patients and the treatment staff know about the specific allocation to the negative pressure wound therapy or standard wound therapy arm. A photo documentation and a computer-based evaluation of the wound images will be performed. This is done centrally by independent examiners, who don`t know neither the patient nor the treatment assignment. It is believed that the application of the negative pressure wound therapy systems compared to standard therapy of diabetic foot wounds will lead more frequent and more rapid to the achievement of complete wound closure and that the use of negative pressure wound therapy is an effective and safe therapy option for the treatment of diabetic foot wounds in inpatient and outpatient care. Patient´s to be included into the study should have either a chronic diabetic foot wound existing longer than 4 weeks whereas dead tissue components must be completely removed by the doctor or a wound after amputation of foot parts. The study treatment may have already started in the hospital if applicable. The further wound treatment will be mainly performed within outpatient care. Study Participants will return to the study centre for regular study visits or even for wound treatment. The comparison of the outcomes of both study arms will give valuable information about the efficacy of negative pressure wound therapy in inpatient as well as outpatient care. These results should be provided until the end of 2016 as a basis for the decision of the Federal Joint Committee to answer the question if the negative pressure wound therapy can be approved as a standard service for reimbursement by health insurance companies.

NCT ID: NCT01454401 Completed - Clinical trials for Diabetic Foot Ulcers

LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

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

The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.

NCT ID: NCT01450943 Completed - Diabetic Foot Ulcer Clinical Trials

VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic

DOLCE
Start date: October 1, 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.

NCT ID: NCT01427569 Completed - Diabetic Foot Ulcer Clinical Trials

Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers

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

The purpose of this study is to determine if topical application of a hydrogel that contains plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a hydrogel alone.