Diabetic Foot Proned Patients
Conditions
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.
Interventions
DRUGLidocaine/prilocaine 1g (topical administration)
Cutaneous blood flow measurement using laser Doppler
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult Men and Women * Presence of diabetes * Signed acknowledgement form
Exclusion criteria
* No signed acknowledgement form * patients under 18 year-old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cutaneous blood flow | Within 3 months after inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
France
Outcome results
None listed