Shear and Pressure Reducing Insoles for the Diabetic Foot
GlideSoft
1 other identifier
interventional
299
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started May 2002
Typical duration for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 10, 2007
CompletedFirst Posted
Study publicly available on registry
July 11, 2007
CompletedJuly 11, 2007
July 1, 2007
July 10, 2007
July 10, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incident foot ulcers
15 months
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of diabetes by WHO criteria
- Ability to provide informed consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diabetica Solutions Inc.lead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Kevin R. Higgins, DPM
San Antonio, Texas, 78217, United States
Related Publications (2)
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;30(1):14-20. doi: 10.2337/dc06-1600.
PMID: 17192326RESULTLavery LA, LaFontaine J, Higgins KR, Lanctot DR, Constantinides G. Shear-reducing insoles to prevent foot ulceration in high-risk diabetic patients. Adv Skin Wound Care. 2012 Nov;25(11):519-24; quiz 525-6. doi: 10.1097/01.ASW.0000422625.17407.93.
PMID: 23080240DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin R Higgins, DPM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 10, 2007
First Posted
July 11, 2007
Study Start
May 1, 2002
Study Completion
January 1, 2005
Last Updated
July 11, 2007
Record last verified: 2007-07