NCT00006438

Brief Summary

The purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles help people with foot deformities to walk better. This study will use modern gait lab techniques to measure the forces on the bottom of the feet and to examine whether there is any effect higher on the leg from the rocker soles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 1997

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 1997

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1999

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2000

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2000

First QC Date

November 3, 2000

Last Update Submit

June 23, 2005

Conditions

Diabetic Feet

Keywords

Rocker solePlantar pressureDiabetic feetInsensate feetgait analysisPedorthicsGait abnormalities

Interventions

Shoes with Rocker SolesDEVICE

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals
  • Insensate individuals

You may not qualify if:

  • History or physical findings of any trunk, back or lower extremity orthopedic or neurologic abnormalities
  • Inability to walk
  • Inability to follow verbal directions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin Gait Lab

Milwaukee, Wisconsin, 53226-0099, United States

Location

Related Links

MeSH Terms

Conditions

Diabetic FootMobility Limitation

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jacqueline Wertsch, M.D.

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 2000

First Posted

November 6, 2000

Study Start

January 1, 1997

Study Completion

December 1, 1999

Last Updated

June 24, 2005

Record last verified: 2000-03

Locations

US(1)