Diabetes Mellitus, Type 2, Diabetic Foot, Diabetic Foot Ulcer
Conditions
Keywords
Diabetes, Insulin, Diabetic Foot, Nutritional supplement, Diamel
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDIAMEL
Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.
DIETARY_SUPPLEMENTPlacebo
Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
It is a double blind study, that is, neither the researcher nor the patient knows if he takes placebo or the active tablet.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of healing | 1 year | The most important outcome measure is to evaluate the early healing of diabetic foot ulcers with the shape and improvements of the foot ulcers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 1 year | Glucose measures with blood test |
| Lipidic control | 1 year | Triglycerides and cholesterol levels with blood test |
| Body mass control | 1 year | Body mass test |
| Renal function control | 1 year | Renal function measures by Creatinine Clearance Blood Test |
| Insulin control | 1 year | 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 |
Countries
Cuba
Outcome results
None listed