Shear and Pressure Reducing Insoles for the Diabetic Foot

Diabetes Clinical Trial

— GlideSoft  

Official title:

Shear and Pressure Reducing Insoles for the Diabetic Foot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499356
• Other study ID #: DK55909
• Status: Completed
• Phase: N/A
• First received: July 10, 2007
• Last updated: July 10, 2007
• Start date: May 2002
• Est. completion date: January 2005

Study information

• Verified date: July 2007
• Source: Diabetica Solutions Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. To evaluate the efficacy of a shear reducing shoe insole (GlideSoft) in reducing the incidence of diabetic foot pathology among high-risk patients. We studied the effectiveness of a shear reducing shoe insole to prevent foot ulcers in high-risk diabetics with sensory neuropathy, a history of a foot ulcer or a history of a partial foot amputation. The study comprised two treatment arms. The first group received standard therapy involving standard therapeutic shoes and insoles, patient education and regular foot evaluations by a physician. The second group received the same standard therapy, but instead of the standard insoles patients used the GlideSoft - a novel shear reducing insole. As determined in the Phase I study, the GlideSoft dramatically reduced shear forces compared to standard insoles, while performing equally well in reducing compressive forces. Patients were followed for 18 months. The primary study outcome was for incident foot ulcers. Our hypothesis was that patients who use the GlideSoft will have fewer ulcers and that these ulcers will be less severe compared to patients evaluated in the Standard Insole Group.

2. 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.

3. To evaluate patient perceived benefits, satisfaction, and compliance with the 2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of diabetes by WHO criteria

• Ability to provide informed consent

• 18-80 years of age

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Amputation
• Diabetes
• Diabetic Foot
• Foot Deformities
• Foot Deformity
• Neuropathy
• Ulceration

Intervention

Device:
• pressure reducing insole

• GlideSoft®

Locations

Country	Name	City	State
United States	Kevin R. Higgins, DPM	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Diabetica Solutions Inc.	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Athanasiou KA, Armstrong DG, Agrawal CM. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007 Jan;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident foot ulcers		15 months

External Links

•   Device developer