NCT00431314

Brief Summary

The aim of this study is to determine the vascular condition of hemodialysis patients with toe pressure measurement, finger pressure measurement and measuring glycated and oxidated proteins by skin autofluorescence. Hypothesis: Lowering of finger pressure/toe pressure during hemodialysis, especially in whom with a arteriovenous fistula, may contribute to critical limb ischemia in the extremities.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

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, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 9, 2008

Status Verified

January 1, 2007

First QC Date

February 2, 2007

Last Update Submit

July 8, 2008

Conditions

End Stage Renal Disease

Keywords

End Stage Renal DiseaseHemodialysisCritical Limb IschemiaAutofluorescence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hemodialysis patients in one hemodialysis centre

You may qualify if:

  • Patients with End Stage Renal Disease with hemodialysis therapy

You may not qualify if:

  • Hemodialysis during the night
  • Dark coloured skin towards unreliable skin autofluorescence measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, ChronicChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesIschemia

Study Officials

  • Henk J Bilo, PhD

    Center of Excellence Diabetes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 5, 2007

Study Start

January 1, 2007

Study Completion

March 1, 2007

Last Updated

July 9, 2008

Record last verified: 2007-01