Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy.

Exclusion Criteria

• •1. Allergic reactions to capsaicin.
• •2. Patients with neuropathic pain of an etiology other than diabetes.
• •3. Patients with peripheral ischemic pain due to diabetic artery disease.
• •4. Patients with unstable glycemic control (glycosylated Hb ≥ 10.5%).
• •5. Amputation of any part of the lower limb.
• •6. Surgery scheduled during the clinical trial.
• •7. Mild painful diabetic neuropathy (\<4 VAS).
• •8. Other serious pathologies:
• •* Documented congestive heart failure or systolic dysfunction (LVEF ≤ 50%).
• •* Previous history of myocardial infarction in the 6 months prior to enrollment.
• •* Uncontrolled hypertension (160/110 mmHg maximum).
• •* Uncontrolled high-risk arrhythmias.
• •* Significant neurological or psychiatric disorders, including psychotic disorders, dementia that prevent patients from understanding and giving informed consent.
• •* Active uncontrolled infection.
• •9. Use other topical pain medications in painful areas.
• •10. History or current problem of substance abuse.
• •11. Pregnant or lactating women. Women of childbearing potential should use effective contraception.
• •12. Participation in another clinical trial with any non-marketed investigational drug during the 90 days prior to inclusion.