Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No Intervention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention