NCT00240175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_1 diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 1, 2012

Status Verified

February 1, 2012

Enrollment Period

6 years

First QC Date

October 13, 2005

Last Update Submit

February 29, 2012

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Quantitative measures of plantar pressure

    1 year

Interventions

No InterventionOTHER

No Intervention

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 pregnant females due to subsequent alterations in gait patterns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Diabetes Institute

San Antonio, Texas, 78207, United States

Location

South Texas Veterans Healthcare System

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hope S Hacker, MD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

August 1, 2005

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 1, 2012

Record last verified: 2012-02

Locations

US(2)