Shear and Pressure Reducing Insoles for the Diabetic Foot

Completed · Not applicable

Conditions studied: Diabetes, Ulceration, Amputation, Foot Deformity, Neuropathy

In brief

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.

Key facts

Study ID

NCT00499356

Run by

Diabetica Solutions Inc.

People needed

299

Starts

2002-05-01

Expected to finish

2005-01-01

Last updated by the study team

2007-07-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetes by WHO criteria
• Ability to provide informed consent
• 18-80 years of age

You may not qualify if…

• Patients with open ulcers or open amputation sites
• Active Charcot arthropathy
• Severe peripheral vascular disease
• Active foot infection
• Dementia
• Impaired cognitive function
• History of drug or alcohol abuse within one year of the study
• Other conditions based on the PI's clinical judgment

Where it is running

• Kevin R. Higgins, DPM — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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