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Foot Deformities clinical trials

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NCT ID: NCT00499356 Completed - Diabetes Clinical Trials

Shear and Pressure Reducing Insoles for the Diabetic Foot

GlideSoft
Start date: May 2002
Phase: N/A
Study type: Interventional

We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear. Although insurance providers spend millions on diabetics’ therapeutic insoles, there is no scientific data about shear or pressure reduction. We will evaluate the optimal bonded materials from Phase I compared to the Glidesoft™ design using the same combination of viscoelastic materials. We evaluate 2 patient groups of 150 patients per arm (300 total) in an 18 month trial. The control group patient arm wore a traditional bonded insole whereas another the second arm receive the GlideSoft™. At baseline, and at the end of the 18 month trial, in-shoe gait lab and in vitro biomechanical parameters measured pressure, shear, and material properties as these changed with wear. This Phase II eighteen (18) month clinical trial evaluated the effectiveness of ShearSole™ reducing the incidence of diabetic ulcers. The overall study hypothesis was that GlideSoft™ provides significant shear reduction as compared to traditional insoles without sacrificing pressure reduction characteristics or durability.

NCT ID: NCT00474344 Completed - Clubfoot Clinical Trials

Genetic Linkage Study of Idiopathic Talipes Equinovarus (ITEV) (Clubfoot)

Start date: August 2004
Phase:
Study type: Observational

The goal of this study is to identify and characterize the genetic loci causing idiopathic talipes equinovarus (clubfoot). The hypothesis is that a few genes account for a substantial fraction of ITEV and that these genes can be identified in defined populations. Towards this goal, in preliminary studies, Dr. Hecht's group has identified two genes, NAT2 and CASP10, which demonstrate evidence for linkage and association to ITEV.

NCT ID: NCT00175708 Completed - Clubfoot Clinical Trials

Pedobarographic Assessments of Clubfoot Treated Patients

Start date: September 2005
Phase:
Study type: Observational

The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment.