Diabetic Foot Proned Patients Clinical Trial
— M2P2Official title:
Cutaneous Microcirculation and Diabetic Foot
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult Men and Women - Presence of diabetes - Signed acknowledgement form Exclusion Criteria: - No signed acknowledgement form - patients under 18 year-old |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | Hospices Civils de Lyon - Centre Hospitalier Lyon Sud | Pierre Benite |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cutaneous blood flow | Within 3 months after inclusion | No | |
| Secondary | Effect of neuropathy on PIV impairment | 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). | Within 3 months after inclusion | No |