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The CareFUL Prevention Trial

2014-08-27 03:25:49 | BioPortfolio

Summary

To assess the efficacy of TrueContour Insoles versus the current standard of care insoles in recurrence of plantar ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar foot ulcer (>1 week but <12 weeks since heeling) and have Loss of Protective Sensation.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Conditions

Plantar Ulcer

Intervention

True Contour Insole, Standard Insole

Status

Not yet recruiting

Source

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:25:49-0400

Clinical Trials [489 Associated Clinical Trials listed on BioPortfolio]

Comparison of Two Different Insole Types in Painful Flexible Flatfoot

The purpose of this study is to compare computer aided design/computer aided manufacturing (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and also...

An Evaluation of a Customized Insole to Provide Relief From Heel Pain Due to Plantar Fasciitis or General Heel Pain When Used in Footwear Over a Period of Four Weeks

The primary objective of this trial will be to demonstrate the ability of a 3/4 length foam insole to provide relief from pain due to plantar fasciitis or general heel pain when used in fo...

Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear

The purpose of this study is to investigate the long term balance-enhancing effects of insoles that are hard and thin for older adults. Thirty older female adults between the ages of 65-84...

Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis

The focus of this project is to determine the immediate efficacy of a combined treatment (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (OA) and the sh...

Study of How An Ankle Strap Changes Effects of Insole Treatment for Knee Osteoarthritis

The goal of this project is to assess the effects of an ankle strap on the effectiveness of a laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static an...

PubMed Articles [5800 Associated PubMed Articles listed on BioPortfolio]

Continuous use of textured insole improve plantar sensation and stride length of people with Parkinson's disease: A pilot study.

Findings involving the acute benefits of textured insoles on gait in people with Parkinson's disease (PD) are still controversial. To our best acknowledge, the continuous use of textured insoles on ga...

Whether Flexible Flatfoot Needs the Treatment? An Observation of Plantar Pressure Effects on Adults with Flexible Flatfoot by Wearing over the Counter Insoles When Walking on Level Surface, Upstairs and Downstairs.

Orthotic insole is one popular physiotherapy for flatfoot. However, the effects and if flexible flatfoot needs the treatment are not clear and how the plantar pressure change while walking upstairs an...

Estimation of Foot Plantar Center of Pressure Trajectories with Low-Cost Instrumented Insoles Using an Individual-Specific Nonlinear Model.

Postural control is a complex skill based on the interaction of dynamic sensorimotor processes, and can be challenging for people with deficits in sensory functions. The foot plantar center of pressur...

The effect of a single textured insole in gait rehabilitation of individuals with stroke.

Rehabilitation interventions designed to restore gait symmetry in individuals with stroke are not always effective. The goal was to evaluate the long-term effect of using a single textured insole in g...

A metric study of insole foot impressions in footwear of identical twins.

Foot impressions are of utmost importance in crime scene investigations. Foot impressions are available in the form of barefoot prints, sock-clad footprints, and as impressions within footwear. Someti...

Medical and Biotech [MESH] Definitions

Inflammation of the thick tissue on the bottom of the foot (plantar fascia) causing HEEL pain. The plantar fascia (also called plantar aponeurosis) are bands of fibrous tissue extending from the calcaneal tuberosity to the TOES. The etiology of plantar fasciitis remains controversial but is likely to involve a biomechanical imbalance. Though often presenting along with HEEL SPUR, they do not appear to be causally related.

A fibromatosis of the plantar fascia characterized by thickening of the fibrous bands on the plantar aponeurosis in the sole of the foot and toes.

A bony outgrowth on the lower surface of the CALCANEUS. Though often presenting along with plantar fasciitis (FASCIITIS, PLANTAR), they are not considered causally related.

A PEPTIC ULCER located in the DUODENUM.

Ulceration of the skin and underlying structures of the lower extremity. About 90% of the cases are due to venous insufficiency (VARICOSE ULCER), 5% to arterial disease, and the remaining 5% to other causes.

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