Cutaneous Microcirculation and Diabetic Foot

Not Applicable

Completed

• Conditions: Diabetic Foot Proned Patients
• Interventions: Drug: Lidocaine/prilocaine 1g (topical administration)

• Registration Number: NCT01963559
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic patients with MPP	Lidocaine/prilocaine 1g (topical administration)	-
Diabetic patients without MPP	Lidocaine/prilocaine 1g (topical administration)	-

Primary Outcome Measures

Name	Time	Method
Cutaneous blood flow	Within 3 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Effect of neuropathy on PIV impairment	Within 3 months after inclusion	Difference in skin vascular response to local application of pressure (PIV) with and without topical application of a local anesthetic cream Lidocaine / prilocaine in all diabetic patients (with and without MPP).

Trial Locations

Locations (1)

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France