Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population|
- Quantitative measures of plantar pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Other: No Intervention
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% will develop foot ulcerations with 6% continuing onto some manner of foot or lower limb amputation. While it has been widely recommended that therapeutic shoes and foot orthotics be utilized in the ongoing care of diabetics with insensate feet, there is limited scientific literature quantifying the actual effects. If the early use of orthotic devices is able to decrease the risk or delay the onset of foot ulceration, this could be an essential treatment strategy for individuals with diabetes or peripheral vascular.
To evaluate the orthotic devices a repeated measure within subject study design is purposed. There will be forty two diabetic subjects rated at Category 1 by the UTHSCSA Podiatry Scale (Peripheral neuropathy, no history of ulceration). Each subject will receive three sets of foot orthotics and a pair of extra-depth athletic shoes. The subjects will receive and wear the orthotics in a randomized order. The orthotics to be tested will vary in materials and morphology. They will be a custom molded trilaminar insert, a prefabricated trilaminar insert without any modifications, and an over-the-counter contoured shoe insert of Plastazote and polyurethane. Plantar pressure measurements will be acquired at baseline and after four weeks of accommodation to each set of foot orthoses. It is anticipated that a participant's involvement with the study will require five months.
This study will help to determine the efficacy of the three different types of foot orthotics and help to establish better guidelines for health care practitioners regarding optimal foot care in diabetes and to assist in collecting data for future grants.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240175
|United States, Texas|
|Texas Diabetes Institute|
|San Antonio, Texas, United States, 78207|
|South Texas Veterans Healthcare System|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Hope S Hacker, MD||The University of Texas Health Science Center at San Antonio|