Trials / Completed
CompletedNCT03583593
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Catalysis SL · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | DIAMEL | Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal. |
| DIETARY_SUPPLEMENT | Placebo | Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal. |
Timeline
- Start date
- 2014-05-23
- Primary completion
- 2017-11-12
- Completion
- 2017-11-30
- First posted
- 2018-07-11
- Last updated
- 2018-07-11
Locations
1 site across 1 country: Cuba
Source: ClinicalTrials.gov record NCT03583593. Inclusion in this directory is not an endorsement.