Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Verified date | June 2018 |
Source | Catalysis SL |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 30, 2017 |
Est. primary completion date | November 12, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Cuba | National Institute of Endocrinology | Vedado | Havana |
Lead Sponsor | Collaborator |
---|---|
Catalysis SL |
Cuba,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year | |
Secondary | Glycemic control | Glucose measures with blood test | 1 year | |
Secondary | Lipidic control | Triglycerides and cholesterol levels with blood test | 1 year | |
Secondary | Body mass control | Body mass test | 1 year | |
Secondary | Renal function control | Renal function measures by Creatinine Clearance Blood Test | 1 year | |
Secondary | 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 | 1 year |
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