Cutaneous Microcirculation and Diabetic Foot

NCT ID: NCT01963559

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-05-31

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.

Conditions

Diabetic Foot Proned Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Diabetic patients with MPP

Group Type: OTHER

Lidocaine/prilocaine 1g (topical administration)

Intervention Type: DRUG

Cutaneous blood flow measurement using laser Doppler

Diabetic patients without MPP

Group Type: OTHER

Lidocaine/prilocaine 1g (topical administration)

Intervention Type: DRUG

Cutaneous blood flow measurement using laser Doppler

Interventions

Lidocaine/prilocaine 1g (topical administration)

Cutaneous blood flow measurement using laser Doppler

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Countries

France

Other Identifiers

2011.661

Identifier Type: -

Identifier Source: org_study_id