Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population
Completed · Phase 1
Conditions studied: Diabetes
In brief
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 population and the more sedentary population with diabetes or peripheral vascular disease (dysvascular). However, there is limited objective scientific data documenting the actual benefits or effectiveness of either customized or over-the-counter foot orthoses. It is the aim of this study to determine the effects of three popular foot orthotics on plantar pressures in diabetic populations. If foot orthoses can be utilized as a preventive treatment option to reduce the risk for foot ulceration by redistributing plantar pressures, then orthoses would be a cost effective solution to a high cost (mental and fiscal) medical impairment.
Key facts
- Study ID
- NCT00240175
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 65
- Starts
- 2005-08-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2012-03-01
Who can join
Age: 18 and older, up to 66. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Texas Diabetes Institute — San Antonio, Texas, United States
- South Texas Veterans Healthcare System — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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