Microvascular Response in Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Microcirculation cutanée et Vasodilatation Induite Par la Pression Non-Nociceptive Chez Les diabètiques

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00160927
• Other study ID #: PHRC 02-03
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2005
• Last updated: March 16, 2007
• Start date: January 2003
• Est. completion date: January 2008

Study information

• Verified date: March 2007
• Source: University Hospital, Angers
• Contact: Jean Louis Saumet, MD PhD
• Phone: +33 (0) 241.35.36.89
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes

Exclusion Criteria:

• Non diabetic neuropathy

• Peripheral arterial disease

• pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• local heating

• iontophoresis

Drug:
• actylcholine

• sodium nitroprusside

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Alfediam, UNIVALOIRE

Country where clinical trial is conducted

France, 

References & Publications (2)

Koïtka 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. — View Citation

Koïtka 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. — View Citation