Shear and Pressure Reducing Insoles for the Diabetic Foot (GlideSoft)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Diabetica Solutions Inc.
ClinicalTrials.gov Identifier:
NCT00499356
First received: July 10, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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
Diabetes
Ulceration
Amputation
Foot Deformity
Neuropathy
Device: pressure reducing insole
Device: GlideSoft®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Shear and Pressure Reducing Insoles for the Diabetic Foot

Resource links provided by NLM:


Further study details as provided by Diabetica Solutions Inc.:

Primary Outcome Measures:
  • Incident foot ulcers [ Time Frame: 15 months ]

Enrollment: 299
Study Start Date: May 2002
Study Completion Date: January 2005
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499356

Locations
United States, Texas
Kevin R. Higgins, DPM
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Diabetica Solutions Inc.
Investigators
Principal Investigator: Kevin R Higgins, DPM
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00499356     History of Changes
Other Study ID Numbers: DK55909
Study First Received: July 10, 2007
Last Updated: July 10, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Diabetica Solutions Inc.:
friction
pressure
insole
ulcer
prevention

Additional relevant MeSH terms:
Congenital Abnormalities
Foot Deformities
Foot Deformities, Congenital
Ulcer
Diabetic Foot
Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 25, 2014