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Microvascular Response in Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by University Hospital, Angers.
Recruitment status was:  Recruiting
Information provided by:
University Hospital, Angers Identifier:
First received: September 9, 2005
Last updated: March 16, 2007
Last verified: March 2007
Vascular and neurological mechanisms are both likely to be involved in foot ulcer. We recently reported on the hand an original transient pressure-induced vasodilation (PIV) during a 5 mmHg/min increase of pressure strain using laser Doppler flowmetry. This physiological response to non noxious external local pressure strain is a widely protective cutaneous mechanism. The impairment of PIV in diabetic subjects may be relevant to the high prevalence of foot ulcer that occurs in these individuals. The aim of the project is to analyse the different physiopathological processes involved in PIV impairment in diabetic subjects as compared to matched controls.

Condition Intervention
Diabetes Mellitus Device: local heating Device: iontophoresis Drug: actylcholine Drug: sodium nitroprusside

Study Type: Observational
Study Design: Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Official Title: Microcirculation cutanée et Vasodilatation Induite Par la Pression Non-Nociceptive Chez Les diabètiques

Further study details as provided by University Hospital, Angers:

Estimated Enrollment: 90
Study Start Date: January 2003
Estimated Study Completion Date: January 2008
Detailed Description:
The whole study is a prospective observational study of diabetic type 1 and type 2 subjects focusing on the various physical, physiopathological or pharmacological mechanisms that may interfere with the normal response of the cutaneous microcirculation.The study is currently conducted under various parallel groups of patients and control subjects matched on age and sexe. Techniques used for the study are only non-invasive investigations such as iontophoresis with laser doppler flowmetry, clinical and paraclinical non-invasive investigation of peripheral neuropathy, ultrasound imaging of peripheral arteries.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diabetes

Exclusion Criteria:

  • Non diabetic neuropathy
  • Peripheral arterial disease
  • pregnancy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00160927

Contact: Jean Louis Saumet, MD PhD +33 (0)
Contact: Pierre Abraham

Centre hospitalier universitaire Recruiting
Angers, France, 49933
Contact: Pierre Abraham, MD, PhD         
Sub-Investigator: Pierre Abraham, MD PhD         
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Jean Louis Saumet, MD PhD Centre Hospitalier Universitaire Angers
  More Information

Publications: Identifier: NCT00160927     History of Changes
Other Study ID Numbers: PHRC 02-03
Study First Received: September 9, 2005
Last Updated: March 16, 2007

Keywords provided by University Hospital, Angers:
Laser doppler flowmetry
endothelial function

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action processed this record on July 27, 2017