Shear and Pressure Reducing Insoles for the Diabetic Foot
Public ClinicalTrials.gov record NCT00499356. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00499356
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 299 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2002
- Primary completion
- Not listed
- Completion
- Dec 31, 2004
- Last update posted
- Jul 10, 2007
2002 – 2005
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kevin R. Higgins, DPM | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00499356, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 10, 2007 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00499356 live on ClinicalTrials.gov.