Healthy VolunteersNCT00152724
Mechanisms of Human Cutaneous Microcirculation in Healthy Volunteers
An observational study of Healthy Volunteers, run by University Hospital, Angers at 1 site in France.
Trial summary
Microvascular dysfunctions are critical events in several diseases including diabetes. This study will develop a methodology for microvascular investigation in human skin. The purpose of the study is to investigate the physiological response of the cutaneous microcirculation to physical, thermal, mechanical or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- pressure strain system, iontophoresis, scopolamin and emla
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Jan 1996to Nov 2008
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers with no clinical signs of, or risk factors for, vascular disease
Who cannot join
- Smokers, Pregnancy, Allergy,
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratoire de Physiologie et Explorations Vasculaires - CHU Angers
Angers, 49033
About this study
Official title: Etude de la Reserve Vasomotrice Microcirculatoire cutanée
Microvascular dysfunctions are critical events in several diseases including diabetes. This study will develop a methodology for microvascular investigation in human skin. The purpose of the study is to investigate the physiological response of the cutaneous microcirculation to physical, thermal, mechanical or chemical stimulations.
Read the detailed description
This study has investigated various aspects of the physiology of the microcirculation in the past years and is still recruiting under parallel protocols of physiological investigations of the neurovascular control of the cutaneous microcirculation.
- Conditions
- Healthy Volunteers
- Being tested
- pressure strain system, iontophoresis, scopolamin, emla, capsaicin, aspirin
- Keywords
- Physiology, Microcirculation, Laser-Doppler Flowmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure strain system, iontophoresisDevice
scopolaminDrug
emlaDrug
capsaicinDrug
aspirinDrug
clopidogrelDrug
celecoxibDrug
indomethacinDrug
acetylcholineDrug
sodium nitroprussideDrug
brethylliumDrug
general and local heatingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of the vasomotor response to stimuli
Measured: 1 hour
Secondary outcomes (1)
Kinetics of the vasomotor response to stimuli
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startJan 1996
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jean Louis SAUMET, MD - PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152724
- Sponsor's protocol ID
- CP96-04
- Status last verified
- Mar 2007
- First submitted
- 8 Sep 2005
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Tartas M, Durand S, Koitka A, Bouye P, Saumet JL, Abraham P. Anodal current intensities above 40 microA interfere with current-induced axon-reflex vasodilatation in human skin. J Vasc Res. 2004 May-Jun;41(3):261-7. doi: 10.1159/000078665. Epub 2004 May 19.
PubMed 15153776Durand S, Fromy B, Humeau A, Sigaudo-Roussel D, Saumet JL, Abraham P. Break excitation alone does not explain the delay and amplitude of anodal current-induced vasodilatation in human skin. J Physiol. 2002 Jul 15;542(Pt 2):549-57. doi: 10.1113/jphysiol.2002.022731.
PubMed 12122152Tartas M, Bouye P, Koitka A, Durand S, Gallois Y, Saumet JL, Abraham P. Early vasodilator response to anodal current application in human is not impaired by cyclooxygenase-2 blockade. Am J Physiol Heart Circ Physiol. 2005 Apr;288(4):H1668-73. doi: 10.1152/ajpheart.00415.2004. Epub 2004 Nov 24.
PubMed 15563538Durand S, Tartas M, Bouye P, Koitka A, Saumet JL, Abraham P. Prostaglandins participate in the late phase of the vascular response to acetylcholine iontophoresis in humans. J Physiol. 2004 Dec 15;561(Pt 3):811-9. doi: 10.1113/jphysiol.2004.069997. Epub 2004 Oct 21.
PubMed 15498811Durand S, Fromy B, Tartas M, Jardel A, Saumet JL, Abraham P. Prolonged aspirin inhibition of anodal vasodilation is not due to the trafficking delay of neural mediators. Am J Physiol Regul Integr Comp Physiol. 2003 Jul;285(1):R155-61. doi: 10.1152/ajpregu.00742.2002.
PubMed 12793996Durand S, Fromy B, Koitka A, Tartas M, Saumet JL, Abraham P. Oral single high-dose aspirin results in a long-lived inhibition of anodal current-induced vasodilatation. Br J Pharmacol. 2002 Oct;137(3):384-90. doi: 10.1038/sj.bjp.0704868.
PubMed 12237259Durand S, Fromy B, Bouye P, Saumet JL, Abraham P. Vasodilatation in response to repeated anodal current application in the human skin relies on aspirin-sensitive mechanisms. J Physiol. 2002 Apr 1;540(Pt 1):261-9. doi: 10.1113/jphysiol.2001.013364.
PubMed 11927685
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de la Reserve Vasomotrice Microcirculatoire cutanée
- ClinicalTrials.gov ID
- NCT00152724
- Acronym / sponsor ID
- CP96-04
- Conditions
- Healthy Volunteers
- Keywords
- Physiology, Microcirculation, Laser-Doppler Flowmetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 1996
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 9 Sep 2005 (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.
Microvascular dysfunctions are critical events in several diseases including diabetes. This study will develop a methodology for microvascular investigation in human skin. The purpose of the study is to investigate the physiological response of the cutaneous microcirculation to physical, thermal, mechanical or chemical stimulations.
Detailed description
This study has investigated various aspects of the physiology of the microcirculation in the past years and is still recruiting under parallel protocols of physiological investigations of the neurovascular control of the cutaneous microcirculation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers with no clinical signs of, or risk factors for, vascular disease
Key exclusion criteria (1 listed)
- Smokers, Pregnancy, Allergy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pressure strain system, iontophoresis | Device | – |
| scopolamin | Drug | – |
| emla | Drug | – |
| capsaicin | Drug | – |
| aspirin | Drug | – |
| clopidogrel | Drug | – |
| celecoxib | Drug | – |
| indomethacin | Drug | – |
| acetylcholine | Drug | – |
| sodium nitroprusside | Drug | – |
| brethyllium | Drug | – |
| general and local heating | Device | – |
Primary outcome
Amplitude of the vasomotor response to stimuli
Time frame: 1 hour
1 secondary outcome
Kinetics of the vasomotor response to stimuli
Time frame: 1 hour
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 1 Nov 2017.
- Results publication: PubMed 15153776Tartas M, Durand S, Koitka A, Bouye P, Saumet JL, Abraham P. Anodal current intensities above 40 microA interfere with current-induced axon-reflex vasodilatation in human skin. J Vasc Res. 2004 May-Jun;41(3):261-7. doi: 10.1159/000078665. Epub 2004 May 19.
- Results publication: PubMed 12122152Durand S, Fromy B, Humeau A, Sigaudo-Roussel D, Saumet JL, Abraham P. Break excitation alone does not explain the delay and amplitude of anodal current-induced vasodilatation in human skin. J Physiol. 2002 Jul 15;542(Pt 2):549-57. doi: 10.1113/jphysiol.2002.022731.
- Results publication: PubMed 15563538Tartas M, Bouye P, Koitka A, Durand S, Gallois Y, Saumet JL, Abraham P. Early vasodilator response to anodal current application in human is not impaired by cyclooxygenase-2 blockade. Am J Physiol Heart Circ Physiol. 2005 Apr;288(4):H1668-73. doi: 10.1152/ajpheart.00415.2004. Epub 2004 Nov 24.
- Results publication: PubMed 15498811Durand S, Tartas M, Bouye P, Koitka A, Saumet JL, Abraham P. Prostaglandins participate in the late phase of the vascular response to acetylcholine iontophoresis in humans. J Physiol. 2004 Dec 15;561(Pt 3):811-9. doi: 10.1113/jphysiol.2004.069997. Epub 2004 Oct 21.
- Results publication: PubMed 12793996Durand S, Fromy B, Tartas M, Jardel A, Saumet JL, Abraham P. Prolonged aspirin inhibition of anodal vasodilation is not due to the trafficking delay of neural mediators. Am J Physiol Regul Integr Comp Physiol. 2003 Jul;285(1):R155-61. doi: 10.1152/ajpregu.00742.2002.
- Results publication: PubMed 12237259Durand S, Fromy B, Koitka A, Tartas M, Saumet JL, Abraham P. Oral single high-dose aspirin results in a long-lived inhibition of anodal current-induced vasodilatation. Br J Pharmacol. 2002 Oct;137(3):384-90. doi: 10.1038/sj.bjp.0704868.
- Results publication: PubMed 11927685Durand S, Fromy B, Bouye P, Saumet JL, Abraham P. Vasodilatation in response to repeated anodal current application in the human skin relies on aspirin-sensitive mechanisms. J Physiol. 2002 Apr 1;540(Pt 1):261-9. doi: 10.1113/jphysiol.2001.013364.
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Screening Protocol
Pain
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.
Jean Louis SAUMET, MD - PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by University Hospital, Angers at 1 site in France.
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 1 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 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Amplitude of the vasomotor response to stimuli (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00152724, which also lists 7 linked publications.
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 1 Nov 2017.