Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.

Inclusion Criteria:

• Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population

Exclusion Criteria:

• Manifestation of hypersensitivity to any component of the product
• Uncooperative patients
• Severe infection
• Debilitating diseases
• Steroid treatment
• Pregnancy