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Diabetic Foot Ulcer clinical trials

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NCT ID: NCT03044132 Completed - Diabetic Foot Ulcer Clinical Trials

DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

Start date: January 15, 2017
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.

NCT ID: NCT03041844 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Enhanced Ultrasound Treatment of Chronic Wounds With Monitoring of Healing and Quality of Life Outcomes

Start date: January 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or diabetic ulcers.

NCT ID: NCT03021811 Completed - Diabetic Foot Ulcer Clinical Trials

EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management

Start date: October 2015
Phase: N/A
Study type: Interventional

Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).

NCT ID: NCT03010319 Completed - Diabetic Foot Ulcer Clinical Trials

PriMatrix for the Management of Diabetic Foot Ulcers

Start date: January 2017
Phase: N/A
Study type: Interventional

The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.

NCT ID: NCT03010215 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

DiabeticMIS1
Start date: January 2010
Phase: N/A
Study type: Interventional

Despite the development of the control of DM and the great interest for the complications of the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon. Being frequently correlated to alteration of the plantar pressures, the surgery treatment is recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve this pathologic case. The purpose of this longitudinal cross-sectional study was to evaluate radiographic and surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic through MIS.

NCT ID: NCT03002155 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers

Start date: January 2017
Phase: N/A
Study type: Interventional

People with diabetes are at risk for life altering complications, including diabetic foot ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing weight on their affected limb for months. These long periods of non-weight bearing can result in severe physical deconditioning, putting these individuals at risk for further health decline. The goal of this pilot, randomized controlled trial is to evaluate the effects of a seated exercise program on clinically meaningful outcomes in people with diabetic foot ulcers. The long-term aim of this research is to improve overall health and quality of life in people with complications from diabetes.

NCT ID: NCT02995863 Completed - Diabetic Foot Ulcer Clinical Trials

This Research Hypothesizes That the Use of a Rigid Rocker Sole Reduces the Recurrence Rate of Diabetic Foot Ulcers in Patients With Peripheral Neuropathy.

Start date: December 10, 2016
Phase: N/A
Study type: Interventional

This research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. The hypothesis of the research is the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.

NCT ID: NCT02994966 Completed - Diabetic Foot Ulcer Clinical Trials

Diabetes Foot Care Clinical Pathway - Orpyx Medical Technologies

DFCCP-Orpyx
Start date: November 2016
Phase: N/A
Study type: Interventional

In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care as one of three significant targets for pan-provincial action. The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment of foot ulcers in an effort to reduce lower limb amputation (LLA) by 50%. The DFCCPP key deliverables apply consistency in assessment, care, treatment and process standards, early intervention and complex wound care management, while optimizing health outcomes. To achieve these deliverables, High Risk Foot Teams (HRFTs) will be implemented across the province starting with three pilot sites (Slave Lake, Brooks, and outpatient clinics at the Peter Lougheed Hospital). The pilot site facilities were selected on the basis of their employing staff with expertise and knowledge in diabetic foot care. The HRFT will assess and treat patients with moderate and high-risk findings, and this care pathway will then be rolled out to all clinicians who perform diabetic foot assessments (Primary Care, Home Care, Diabetes Centers, First Nations Reserves, etc.). In conjunction with the DFCCPP, we will evaluate the efficacy of a technological device developed by Alberta-based small-medium enterprise (SME) to improve diabetic foot outcomes by preventing future wounds in high-risk patients who have recently been treated for active foot ulcers. This technology is the SurroSense Rx® smart insole system (Orpyx Medical Technologies Inc., Calgary AB), a device that provides dynamic offloading guidance to patients, in addition to enabling ongoing adherence tracking by the HRFT. It is hypothesized that early wound detection and treatment will ultimately lead to improvements in wound prevalence, chronic wound care, and reduce the need for surgical intervention, including LLA.

NCT ID: NCT02990832 Withdrawn - Diabetic Foot Ulcer Clinical Trials

Diabetes Foot Care Clinical Pathway Project - Exciton Technologies Inc

DFCCP-Exciton
Start date: January 2017
Phase: N/A
Study type: Interventional

In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care as 1 of 3 significant targets for pan-provincial action. Of 210,000 people with diabetes in Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were 425 lower limb amputations (LLA). Moreover, there is a tremendous reduction in quality of life of the patients and attendant negative effects on their families. The 5-year mortality rate after new-onset diabetic foot ulcer is 43-55% and as high as 74% for patients undergoing LLA (CIHI, 2013). The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment of foot ulcers in an effort to reduce LLA by 50% by implementing High Risk Foot Teams (HRFTs) across the province starting with 3 Pilot sites. Existing staff with expertise and knowledge in diabetic foot care will assess and treat patients with moderate and high-risk findings. In conjunction with the DFCCPP, the efficacy of a technological advancement developed by an Alberta-based small-to-medium enterprise (SME) to improve diabetic foot outcomes will be evaluated. Exsalt® SD7 Wound Dressings (Exciton Technologies, Edmonton, AB) have been demonstrated in-vitro and in-vivo to provide rapid and effective antibacterial activity in an easy-to-use format, thus creating an enhanced wound healing environment while supporting patient quality of life. The objective of the proposed work is twofold, namely 1) to quantify clinical efficacy of exsalt® Wound Dressings on locally infected diabetic foot ulcers not progressing to healing under the current standard of care: evaluating key indicators of infection, Infectious Diseases Society of America (IDSA) wound classification, and wound size; identifying benefits to foot ulcer healing and 2) to evaluate subjective patient outcomes: satisfaction, perceived benefit, compliance. Evaluating the benefits of utilization of the Exciton exsalt® Wound Dressings when combined with the DFCCP.

NCT ID: NCT02989961 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Safety and Efficacy of Resticutis Compared to Platelet-Poor Plasma for Treating Diabetic Foot Ulcers

Start date: November 15, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator.