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Sponsors and Collaborators: |
University Hospital, Angers Alfediam UNIVALOIRE |
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Information provided by: | University Hospital, Angers |
ClinicalTrials.gov Identifier: | NCT00160927 |
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 |
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Diabetes Mellitus |
Device: local heating Device: iontophoresis Drug: actylcholine Drug: sodium nitroprusside |
Study Type: | Observational |
Study Design: | Natural History, Cross-Sectional, Case Control, Retrospective/Prospective Study |
Official Title: | Microcirculation cutanée et Vasodilatation Induite Par la Pression Non-Nociceptive Chez Les diabètiques |
Estimated Enrollment: | 90 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | January 2008 |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean Louis Saumet, MD PhD | +33 (0) 241.35.36.89 | |
Contact: Pierre Abraham |
France | |
Centre hospitalier universitaire | Recruiting |
Angers, France, 49933 | |
Contact: Pierre Abraham, MD, PhD | |
Sub-Investigator: Pierre Abraham, MD PhD |
Principal Investigator: | Jean Louis Saumet, MD PhD | Centre Hospitalier Universitaire Angers |
Study ID Numbers: | PHRC 02-03 |
Study First Received: | September 9, 2005 |
Last Updated: | March 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00160927 |
Health Authority: | France: Ministry of Health |
microcirculation Laser doppler flowmetry neuropathy endothelial function |
Nitric Oxide Metabolic Diseases Nitroprusside Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Nitric Oxide Donors |