Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers

Exclusion Criteria

• •1. age less than 25 years or greater than 85 years
• •2. Skin ulceration of other than diabetic etiology
• •3. diagnosis of type I diabetes
• •4. use of any other serum glucose modifying agent, other than stable prescribed anti-diabetic medication regimen within 12 weeks of screening visit
• •5. use of nutritional supplements specifically for anti-oxidative purposes (e.g., multivitamins allowed)
• •6. history of collagen vascular disease
• •7. taking corticosteroids in any dose, by any route
• •8. no history of therapy with pentoxyphylline or cilostazol for 2 months prior to the screening visit and for the duration of the study
• •9. history of any intestinal disease that might interfere with absorption of study products
• •10. any active malignancy or history of malignancy within 3 years of the screening visit,, except basal cell carcinoma or cervical carcinoma in situ curatively treated
• •11. screening AST, ALT, alkaline phosphatase, bilirubin \>1.3 times the upper limit of normal for the reference laboratory
• •12. serum creatinine \>3.0
• •13. diabetes mellitus not on stable therapy for at least 3 months
• •14. history of chronic pancreatitis
• •15. uncontrolled hypertension (DBP \>100, SPB \>160)
• •16. unstable angina, other uncontrolled cardiac disease including NYHA CHF Class III or IV
• •17. pregnant or lactating women
• •18. known history of allergies to citrus, diosmin, or Alka-4 Complex
• •19. history of substance abuse, or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
• •20. Consumption of more than one (1) unit of alcohol daily. For the purposes of this study a unit of alcohol is defined as 12 oz. of beer, 6 oz. of wine or 1.5 oz. of hard spirits
• •21. Concomitant use of chlorzoxazone, diclofenac or metronidazole
• •22. any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study
• •23. participation in another clinical trial within 30 days or 7 half-lives of the prior study product, whichever is longer, of the screening visit