NCT00160927

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 19, 2007

Status Verified

March 1, 2007

First QC Date

September 9, 2005

Last Update Submit

March 16, 2007

Conditions

Keywords

microcirculationLaser doppler flowmetryneuropathyendothelial function

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes

You may not qualify if:

  • Non diabetic neuropathy
  • Peripheral arterial disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

RECRUITING

Related Publications (2)

  • 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. doi: 10.1016/j.mvr.2003.12.001.

    PMID: 15020212BACKGROUND
  • 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. doi: 10.2337/diabetes.53.3.721.

    PMID: 14988257BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

IontophoresisNitroprusside

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative TechniquesFerricyanidesCyanidesAnionsIonsElectrolytesInorganic ChemicalsFerric CompoundsIron CompoundsHydrogen CyanideNitrogen Compounds

Study Officials

  • Jean Louis Saumet, MD PhD

    Centre Hospitalier Universitaire Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Louis Saumet, MD PhD

CONTACT

Pierre Abraham

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

January 1, 2003

Study Completion

January 1, 2008

Last Updated

March 19, 2007

Record last verified: 2007-03

Locations