NCT00013286

Brief Summary

This project will identify risk factors for diabetic foot ulcer by studying the relationship between endothelial dysfunction and foot ulcer risk. A fundamental defect in type 1 and 2 diabetic subjects is impaired vasodilatory reserve which is reflected in the dysfunction of endothelium-dependent vasodilation. Findings thus far point to an important role of the microvasculature in the development of diabetic foot ulcer and amputation. In this study a a well-characterized cohort of 750 diabetic veterans without foot ulcer will be followed over 3-years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1999

Typical duration for all trials

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, 1999

Completed
1.5 years 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
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

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

Diabetes mellitus, foot ulcer, endothelium

Interventions

Prevention Diabetic Foot UlcerDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Diabetic patients with foot ulcers

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 FootDiabetes MellitusFoot Ulcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFoot 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 & Review Section (PARS), Rehabilitation Research & Development Service

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Start

October 1, 1999

Study Completion

September 1, 2002

Last Updated

January 21, 2009

Record last verified: 2001-01

Locations

US(1)