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Microvascular Response in Diabetes Mellitus - Article


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CPAP Device

Clinical Trial: Microvascular Response in Diabetes Mellitus

This study is currently recruiting patients.
Verified by University Hospital Angers September 2005

Sponsors and Collaborators: University Hospital Angers
ALFEDIAM
UNIVALOIRE
Information provided by: University Hospital Angers
ClinicalTrials.gov Identifier: NCT00160927

Purpose

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 copmpared to matched controls.
Condition Intervention
Diabetes Mellitus
  Device: local heating
 Device: iontophoresis
 Drug: actylcholine
 Drug: sodium nitroprusside

MedlinePlus related topics:  Diabetes

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

Further Study Details: 

Expected Total Enrollment:  90

Study start: January 2003;  Expected completion: January 2007
Last follow-up: January 2007;  Data entry closure: January 2007

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Diabetes

Exclusion Criteria:

  • Non diabetic neuropathy
  • Peripheral arterial disease
  • pregnancy

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00160927

Jean Louis Saumet, MD PhD      +33 (0) 241.35.36.89 
Pierre Abraham    

France
      Centre hospitalier universitaire, Angers,  49933,  France; Recruiting
Pierre Abraham, MD, PhD
Pierre Abraham, MD PhD,  Sub-Investigator

Study chairs or principal investigators

Jean Louis Saumet, MD PhD,  Principal Investigator,  Centre Hospitalier Universitaire Angers   

More Information

Publications

Koitka A, Legrand-Fernandez MS, Abraham P, Fizanne L, Fromy B, Sigaudo-Roussel D, Saumet JL. Low skin temperature impairs the cutaneous vasodilator response to local progressive pressure strain. Microvasc Res. 2004 Mar;67(2):203-6.

Koitka A, Abraham P, Bouhanick B, Sigaudo-Roussel D, Demiot C, Saumet JL. Impaired pressure-induced vasodilation at the foot in young adults with type 1 diabetes. Diabetes. 2004 Mar;53(3):721-5.

Study ID Numbers:  PHRC 02-03
Last Updated:  September 11, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00160927
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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