End Stage Renal DiseaseNCT00431314
Effect of Hemodialysis on Toe Pressure- and Finger Pressure and Skin Autofluorescence in Hemodialysis Patients
An observational study of End Stage Renal Disease, run by Isala.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hemodialysis patients in one hemodialysis centre
Who may be able to join
- Patients with End Stage Renal Disease with hemodialysis therapy
Who cannot join
- Hemodialysis during the night
- Dark coloured skin towards unreliable skin autofluorescence measurements
About this study
Official title: The Effect of Hemodialysis on Toe Pressure- and Finger Pressure Measurements and Measurement of Skin Autofluorescence; a Pilot Study in the Assessment of Critical Limb Ischemia in Hemodialysis Patients.
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.
Read the detailed description
- To determine the macrovascular status of hemodialysis patients by measuring toe pressure, finger pressure and skin autofluorescence.
- Measuring toe- and finger pressure before and during hemodialysis to determine the chance of developing critical limb ischemia in the extremities.
- To assess the differences in finger pressure in hemodialysis patients before and during hemodialysis in patients with either arteriovenous fistula in the upper extremity or not.
- To predict mortality and cardiovascular disease by determine the fastness of accumulation of Advanced-Glycation-Endproducts (this concerns follow-up measurements of skin autofluorescence; another study has collected data of skin autofluorescence in hemodialysis patients in our centre in 2003)
- Conditions
- End Stage Renal Disease
- Keywords
- End Stage Renal Disease, Hemodialysis, Critical Limb Ischemia, Autofluorescence
- Medical subject headings
- Kidney Failure, Chronic, Chronic Limb-Threatening Ischemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startJan 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Investigators
- Henk J Bilo, PhD, Study director, Center of Excellence Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431314
- Sponsor's protocol ID
- HD
- Status last verified
- Jan 2007
- First submitted
- 2 Feb 2007
- Last updated
- 9 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hemodialysis on Toe Pressure- and Finger Pressure Measurements and Measurement of Skin Autofluorescence; a Pilot Study in the Assessment of Critical Limb Ischemia in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT00431314
- Acronym / sponsor ID
- HD
- Conditions
- End Stage Renal Disease
- Keywords
- End Stage Renal Disease, Hemodialysis, Critical Limb Ischemia, Autofluorescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Study start
- Jan 2007
- Study completion
- Mar 2007 (actual)
- First posted
- 5 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- To determine the macrovascular status of hemodialysis patients by measuring toe pressure, finger pressure and skin autofluorescence.
- Measuring toe- and finger pressure before and during hemodialysis to determine the chance of developing critical limb ischemia in the extremities.
- To assess the differences in finger pressure in hemodialysis patients before and during hemodialysis in patients with either arteriovenous fistula in the upper extremity or not.
- To predict mortality and cardiovascular disease by determine the fastness of accumulation of Advanced-Glycation-Endproducts (this concerns follow-up measurements of skin autofluorescence; another study has collected data of skin autofluorescence in hemodialysis patients in our centre in 2003)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hemodialysis patients in one hemodialysis centre
Key inclusion criteria (1 listed)
- Patients with End Stage Renal Disease with hemodialysis therapy
Key exclusion criteria (2 listed)
- Hemodialysis during the night
- Dark coloured skin towards unreliable skin autofluorescence measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk J Bilo, PhD study director
Center of Excellence Diabetes
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by Isala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2008.