NCT00152724

Brief 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 chemical stimulations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1996

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 1, 2017

Status Verified

March 1, 2007

Enrollment Period

12.8 years

First QC Date

September 8, 2005

Last Update Submit

October 30, 2017

Conditions

Keywords

PhysiologyMicrocirculationLaser-Doppler Flowmetry

Outcome Measures

Primary Outcomes (1)

  • Amplitude of the vasomotor response to stimuli

    1 hour

Secondary Outcomes (1)

  • Kinetics of the vasomotor response to stimuli

    1 hour

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers with no clinical signs of, or risk factors for, vascular disease

You may not qualify if:

  • Smokers, Pregnancy, Allergy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire de Physiologie et Explorations Vasculaires - CHU Angers

Angers, 49033, France

Location

Related Publications (7)

  • 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.

  • Durand 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.

  • Tartas 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.

  • Durand 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.

  • Durand 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.

  • Durand 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.

  • Durand 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.

MeSH Terms

Interventions

IontophoresisLidocaine, Prilocaine Drug CombinationCapsaicinAspirinClopidogrelCelecoxibIndomethacinAcetylcholineNitroprusside

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative TechniquesLidocaineAcetanilidesAnilidesAmidesOrganic ChemicalsPrilocaineAniline CompoundsAminesDrug CombinationsPharmaceutical PreparationsPolyunsaturated AlkamidesAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsSalicylatesHydroxybenzoatesTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzenesulfonamidesSulfonamidesSulfonesPyrazolesAzolesIndolesBiogenic AminesFerricyanidesCyanidesAnionsIonsElectrolytesInorganic ChemicalsFerric CompoundsIron CompoundsHydrogen CyanideNitrogen Compounds

Study Officials

  • Jean Louis SAUMET, MD - PhD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

January 1, 1996

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 1, 2017

Record last verified: 2007-03

Locations