Status:
COMPLETED
Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Diabetes
Eligibility:
All Genders
18-66 years
Phase:
PHASE1
Brief Summary
Foot orthotics or shoe inserts are currently utilized as a common conservative treatment option for a wide variety of foot disorders. This treatment is used for both the relatively healthy active popu...
Detailed Description
It is estimated that over 17 million people are affected with diabetes with more than 8 million remaining undiagnosed in the United States alone. Of the total diabetic population, approximately 15% wi...
Eligibility Criteria
Inclusion
- normal gait pattern
- Category 1 diabetic rating by the UTHSCSA Podiatry scale - Category 1 diabetics have documentable peripheral neuropathy but no history of foot ulceration.
- males or females between the ages of 18 and 66
Exclusion
- neuromuscular deficits
- no foot abnormalities (hammer toes, pes cavus) that requires specialized footwear. The participant must be tolerant of the study shoes to be supplied. To address this matter a four week accommodation period to the study shoe will be required for inclusion to the study.
- No pregnant females due to subsequent alterations in gait patterns
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00240175
Start Date
August 1 2005
End Date
August 1 2011
Last Update
March 1 2012
Active Locations (2)
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1
Texas Diabetes Institute
San Antonio, Texas, United States, 78207
2
South Texas Veterans Healthcare System
San Antonio, Texas, United States, 78229