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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.
Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.
National Institute of Endocrinology
Vedado, La Habana, Cuba
Time of healing
The most important outcome measure is to evaluate the early healing of diabetic foot ulcers with the shape and improvements of the foot ulcers.
Time frame: 1 year
Glycemic control
Glucose measures with blood test
Time frame: 1 year
Lipidic control
Triglycerides and cholesterol levels with blood test
Time frame: 1 year
Body mass control
Body mass test
Time frame: 1 year
Renal function control
Renal function measures by Creatinine Clearance Blood Test
Time frame: 1 year
Insulin control
Insulin levels measured by the Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population
Time frame: 1 year
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