Cutaneous Microcirculation and Diabetic Foot (M2P2)

Civil Hospices of Lyon

Status: Completed

Conditions: Diabetic Foot Proned Patients

Treatments: Drug: Lidocaine/prilocaine 1g (topical administration)

Study type: Interventional

Funder types: Other

Identifiers

NCT01963559

2011.661

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Diabetic patients with MPP

Other group

Treatment:

Drug: Lidocaine/prilocaine 1g (topical administration)

Diabetic patients without MPP

Other group

Treatment:

Drug: Lidocaine/prilocaine 1g (topical administration)