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Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00240175
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : March 1, 2012
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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 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.

Condition or disease Intervention/treatment Phase
Diabetes Other: No Intervention Phase 1

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% 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population
Study Start Date : August 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Intervention Details:
  • Other: No Intervention
    No Intervention

Primary Outcome Measures :
  1. Quantitative measures of plantar pressure [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00240175

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United States, Texas
Texas Diabetes Institute
San Antonio, Texas, United States, 78207
South Texas Veterans Healthcare System
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
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Principal Investigator: Hope S Hacker, MD The University of Texas Health Science Center at San Antonio
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Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT00240175    
Other Study ID Numbers: 056-0011-010
VVISN Project # 0001
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012