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Sponsors and Collaborators: |
Diabetica Solutions Inc. National Institutes of Health (NIH) |
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Information provided by: | Diabetica Solutions Inc. |
ClinicalTrials.gov Identifier: | NCT00499356 |
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.
Condition | Intervention |
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Diabetes Ulceration Amputation Foot Deformity Neuropathy |
Device: pressure reducing insole Device: GlideSoft® |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Shear and Pressure Reducing Insoles for the Diabetic Foot |
Enrollment: | 299 |
Study Start Date: | May 2002 |
Study Completion Date: | January 2005 |
To evaluate changes in pressure and shear reducing capabilities of the two. To evaluate changes in pressure and shear reducing capabilities of the GlideSoft and standard insoles over the duration of use.
We measured in-shoe pressures and in-vitro shear forces at the foot-insole interface at the beginning of the study and after patients wore the insole for four months or one “standard cycle of wear”. We used the Novel Electronics, Inc. Pedar in-shoe pressure system to measure the interface between the foot and insole and the Shear Force Tester (see Phase I report) to evaluate shear forces. We expected that the GlideSoft would significantly reduce shear forces and provide equivalent reduction in vertical forces at both the day 0 evaluation and day 120 evaluations.
We measured in-shoe pressures and in-vitro shear forces at the foot-insole interface at the beginning of the study and after patients wore the insole for four months or one “standard cycle of wear”. We used the Novel Electronics, Inc. Pedar in-shoe pressure system to measure the interface between the foot and insole and the Shear Force Tester (see Phase I report) to evaluate shear forces. We expected that the GlideSoft would significantly reduce shear forces and provide equivalent reduction in vertical forces at both the day 0 evaluation and day 120 evaluations.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | DK55909 |
Study First Received: | July 10, 2007 |
Last Updated: | July 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00499356 |
Health Authority: | United States: Institutional Review Board |
friction pressure insole ulcer prevention |
Foot Ulcer Diabetic Neuropathies Skin Diseases Ulcer Diabetes Mellitus Vascular Diseases Endocrine System Diseases Diabetic Angiopathies |
Musculoskeletal Diseases Endocrinopathy Congenital Abnormalities Skin Ulcer Foot Deformities Diabetes Complications Diabetic Foot Leg Ulcer |
Cardiovascular Diseases |