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...
Date First Received: September 8, 2005
Last Updated: March 16, 2007
Verified by: University Hospital, Angers, March 2007
Clinical Trial Phase: Phase 4 | Start Date: January 1996
Overall Status: Recruiting
Estimated Enrollment: 85
Brief Summary
Official Title: “Etude de la Reserve Vasomotrice Microcirculatoire cutanée”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Device: pressure strain system, iontophoresis
- Drug: scopolamin
- Drug: emla
- Drug: capsaicin
- Drug: aspirin
- Drug: clopidogrel
- Drug: celecoxib
- Drug: indomethacin
- Drug: acetylcholine
- Drug: sodium nitroprusside
- Drug: brethyllium
- Device: general and local heating
Outcome Measures for this Clinical Trial
Primary Measures
- Amplitude of the vasomotor response to stimuli
Secondary Measures
- Kinetics of the vasomotor response to stimuli
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy volunteers with no clinical signs of, or risk factors for, vascular disease
Exclusion Criteria:
- Smokers, Pregnancy, Allergy,
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital, Angers
Overall Clinical Trial Officials and Contacts
Jean Louis SAUMET, MD - PhD Principal Investigator University Hospital, Angers
Overall Contact: Pierre ABRAHAM, MD, PhD (0)2-41-35-46-17 piabraham@chu-angers.fr
Related Publications
Citations Reporting Results
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. 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.
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. 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. 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.
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.
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.
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00152724
Study ID Number: CP96-04
ClinicalTrials.gov Identifier: NCT00152724
Health Authority: France: Ministry of Health
Clinical Trials Authorship and Review
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