Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
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|ClinicalTrials.gov Identifier: NCT03583593|
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer Diabetic Foot Diabetes Mellitus, Type 2||Dietary Supplement: DIAMEL Dietary Supplement: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, 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.|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer|
|Actual Study Start Date :||May 23, 2014|
|Actual Primary Completion Date :||November 12, 2017|
|Actual Study Completion Date :||November 30, 2017|
Study group that receives the active product.
Dietary Supplement: DIAMEL
Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.
Placebo Comparator: Placebo
Control group receiving double-blind placebo.
Dietary Supplement: Placebo
Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.
- Time of healing [ Time Frame: 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.
- Glycemic control [ Time Frame: 1 year ]Glucose measures with blood test
- Lipidic control [ Time Frame: 1 year ]Triglycerides and cholesterol levels with blood test
- Body mass control [ Time Frame: 1 year ]Body mass test
- Renal function control [ Time Frame: 1 year ]Renal function measures by Creatinine Clearance Blood Test
- Insulin control [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583593
|National Institute of Endocrinology|
|Vedado, Havana, Cuba, 10400|