NCT00013299

Brief Summary

This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
427

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2000

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2001

First QC Date

March 14, 2001

Last Update Submit

January 20, 2009

Conditions

Diabetic Foot Ulcers

Keywords

Foot ulcers, amputation prevention, diabetes, footwear, insoles

Interventions

Prevention of Diabetic UlcersDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Diabetics with foot ulcerations

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VAMC, Seattle, WA

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Diabetic FootFoot UlcerDiabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesFoot DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • John Fryer, Ph.D. Asst. Director

    Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

  • Wijegupta Ellepola, Program Analyst

    Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Start

October 1, 2000

Study Completion

April 1, 2001

Last Updated

January 21, 2009

Record last verified: 2001-01

Locations

US(1)