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Diabetic Foot clinical trials

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NCT ID: NCT01859117 Completed - Clinical trials for Peripheral Arterial Disease

Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects With PAD and DFU

Start date: May 2013
Phase: Phase 1
Study type: Interventional

This clinical study is being conducted to assess the safety and determine the maximum tolerated dose (MTD) of PDA-002 [human placenta-derived cells] administered into the lower leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer healing. This study will also help to find the best dose of PDA-002 to use in future studies.

NCT ID: NCT01844479 Completed - Diabetic Foot Ulcer Clinical Trials

Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer

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

In this pilot study, the first objective is to bench test a novel shear reducing insole and compare it to current standard insoles and shoes. The second objective is to study twenty-seven insensate diabetes patients with pre-ulcerative foot callus to examine for changes in spatial temporal gait including gait initiation, risk of falling, static and dynamic balance, and plantar temperature response to walking and consecutive plantar stress in both footwear conditions.

NCT ID: NCT01835379 Completed - Diabetic Foot Ulcer Clinical Trials

Study of Oasis Ultra in Diabetic Foot Ulcers

Start date: May 2013
Phase: Phase 4
Study type: Interventional

Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra. The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot ulcers to heal than wounds treated with regular medical care. Subjects will have their diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .

NCT ID: NCT01831804 Completed - Wound Healing Clinical Trials

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863

Start date: June 17, 2013
Phase: Phase 1
Study type: Interventional

This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects with diabetic foot ulcers. Part A is designed to evaluate single applications of GSK1278863 in one cohort of healthy volunteers (intact skin) and approximately 3 cohorts of diabetic subjects. Part B is designed to evaluate first single, and then repeat applications of GSK1278863 in diabetics, both in the clinic and by subjects at home. Part B will include approximately 3 cohorts in which the concentration of drug applied will be determined by pharmacokinetic data from Part A and earlier cohorts in Part B.

NCT ID: NCT01814267 Completed - Diabetes Clinical Trials

Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management

AIRPEDIA
Start date: March 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers. Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes specialist or 2/innovative care (telemedicine group). the health insurance system perspective is adopted.

NCT ID: NCT01813305 Completed - Diabetes Mellitus Clinical Trials

CSTC1 for Diabetic Foot Ulcers Phase II Study

Start date: July 9, 2014
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.

NCT ID: NCT01770639 Completed - Diabetic Foot Clinical Trials

A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy

Start date: January 2013
Phase: N/A
Study type: Observational

The aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.

NCT ID: NCT01731808 Completed - Diabetic Foot Ulcer Clinical Trials

Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study

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

The purpose of the study is to evaluate the feasibility and effectiveness of a physician directed nurse managed earlier outpatient counselling intervention for patients with diabetic foot ulceration. For the purpose effectiveness is defined in two ways.1) as a reduction in hospital readmissions for complication for foot ulcers such as amputation or increased severity of the ulcer and 2) reduction in amputations, readmission rates. Selected covariates (self-efficacy,self-management, social support and depression) will be included to estimate predictors for readmission and amputation.

NCT ID: NCT01710553 Completed - Diabetic Foot Clinical Trials

BE STUDY OF METFORMIN GSK 1000mg

BA/BE 199/11
Start date: July 2012
Phase: Phase 2
Study type: Interventional

A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study to demonstrate the bioequivalence of Metformin 1000 mg tablets manufactured by Savipharm J.S.C, Vietnam and Glucophage® 1000 mg tablets of Merck Sante, France in healthy adult human male subjects under fasting condition

NCT ID: NCT01710540 Completed - Diabetic Foot Clinical Trials

BE Study of Metformin GSK 850mg

BA/BE 198/11
Start date: August 2012
Phase: Phase 2
Study type: Interventional

A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study to demonstrate the bioequivalence of Metformin 850 mg tablets manufactured by Savipharm J.S.C, Vietnam and Glucophage® 850 mg tablets of Merck Sante, France, in healthy adult human male subjects under fasting condition.