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Clinical Trials/NCT01963559
NCT01963559
Completed
Not Applicable

Cutaneous Microcirculation and Diabetic Foot

Hospices Civils de Lyon1 site in 1 country80 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Lidocaine/prilocaine 1g (topical administration)
Conditions
Diabetic Foot Proned Patients
Sponsor
Hospices Civils de Lyon
Enrollment
80
Locations
1
Primary Endpoint
Cutaneous blood flow
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without DF. Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced Vasodilation (PIV) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. This gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. The main objective of this study is to show that PIV, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of DF, taking into account the influence of age and neuropathy.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult Men and Women
  • Presence of diabetes
  • Signed acknowledgement form

Exclusion Criteria

  • No signed acknowledgement form
  • patients under 18 year-old

Arms & Interventions

Diabetic patients with MPP

Intervention: Lidocaine/prilocaine 1g (topical administration)

Diabetic patients without MPP

Intervention: Lidocaine/prilocaine 1g (topical administration)

Outcomes

Primary Outcomes

Cutaneous blood flow

Time Frame: Within 3 months after inclusion

Secondary Outcomes

  • Effect of neuropathy on PIV impairment(Within 3 months after inclusion)

Study Sites (1)

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