NCT01556984

Brief Summary

Endothelial dysfunction is the early step of atherosclerosis. Therefore, the investigators hypothesize that digital subtraction angiography (DSA) can damage endothelial function. In this study, the investigators will select 200 diabetic patients who have a DSA for diabetic foot screening. Also, the investigators will select 100 healthy subjects as controls. The endothelial function will be determined by high resolution ultrasound before and after DSA. The investigators will observe the changes of endothelial function after DSA assay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 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

First Submitted

Initial submission to the registry

March 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

10 months

First QC Date

March 15, 2012

Last Update Submit

June 12, 2015

Conditions

Diabetes

Keywords

diabetic footdigital subtraction angiographyendothelial functionPatients with diabetesAge 40 to 70 years oldEndothelial function are determined

Outcome Measures

Primary Outcomes (1)

  • The changes of endothelial function

    10 months

Study Arms (2)

DSA group

Other: DSA assay

control group

Interventions

DSA assayOTHER

All patients with diabetic foot perform a DSA assay. Before and after DSA, endothelial function will be measured.

DSA group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We will select 200 patients with diabetes. DSA will be taken for this group. Endothelial function will be measured before and after DSA. In the meantime, 100 healthy subjects will be selected as controls.

You may qualify if:

  • Patients with diabetic foot
  • Age 40 to 70 years old

You may not qualify if:

  • Heart failure
  • Renal failure
  • Acute infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan General Hospital

Wuhan, Hubei, 430070, China

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Wuhan General Hospital

Study Record Dates

First Submitted

March 15, 2012

First Posted

March 19, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

CN(1)